The FRÍO® wallet is classified as a medical device.
It is FDA registered (establishment registration number 3008447608): please click here to access the FDA certificate.
The wallet carries the CE Mark (Class 1 Medical Device) and this mark is shown on the product label.
UK tested: the FRÍO® has been extensively tested by the British Medical Devices Evaluation Unit and the crystals contained in the wallet conform to relevant British Safety Standards.
Please see the link to the Government's website for comprehensive information related to transportation of cooling gel packs for essential medical purposes:
The gov.uk website states:
Essential medical equipment
You can take medical equipment with you if it's essential for your journey. The equipment is screened seperately and you must show documentation from a qualified medical professional, such as a letter from your doctor.
Whilst we can advise that the airports and airlines are well used to diabetic travellers carrying FRÍO® wallets, it is best to check ahead of travel by advising the airline.
If you are travelling from a provincial airport, we would recommend calling the airline and airport ahead of travel to be on the safe side.
What is incorrectly suggested in the information published is that a cooling gel pack (your FRÍO® wallet) can go in 'hold' luggage - insulin should not be transported in your suitcase as it may freeze in the hold - it should be carried in your hand luggage.
GP's letter: we always recommend that FRÍO® users take a letter from their GP (or a prescription) stating their requirement to carry insulin.
When you check-in at the airport advise the the check-in clerk that you are a carrying essential medical equipment - your cooling gel pack (FRÍO®) and have your GP's letter or your prescription to hand.
Who is eligible for VAT Relief?
VAT law states that you must be 'chronically sick or disabled' to qualify for VAT relief.
A person is 'chronically sick or disabled' if they either:
• have a physical or mental impairment that has a long-term and severe effect on their ability to carry out everyday activities; or
• have a condition that doctors treat as a chronic sickness - like diabetes, for example, or
• are terminally ill.
Chronic Illnesses include:
• Arthritis etc;
• As advised by your GP/Consultant.
VAT Exemption Declaration
When ordering on-line, once you are in the check-out and payment part of the process, you have the option to complete the VAT exemption declaration on-line. Completing the declaration on-line ensures that you will not be charged VAT of 20%. If you forget to complete this information, you will be sent a form with your order that requires completion and returning to FRÍO® UK Limited. The VAT charged will then be credited to the credit card used to make the purchase.
Alternatively, click on the link to view and/or print a VAT Exemption Declaration
The FRIO® maintains the required temperature range - room temperature - for in-use insulin. Please note that it is not a 'fridge alternative.
Many 'in-use' medications can be stored or transported at room temperature - check your manufacturer's information leaflet for your specific medication or, for further advice, call our Customer Support team on 01437 741700.
If you would like to check the storage conditions of your medication on-line, please refer to the website www.medicines.org.uk/EMC/ or click on the link where you can access the electronic medical compendium.
28 days (one month) - this is the life of most* in-use insulin.
* Check your manufacturer's information leaflet for your specific medication, noting that Novo Nordisk states 6 weeks for some brands but it is essential that you check the leaflet.
Please read the full explanation below:
The FRIO® travel wallet is an evaporative cooling unit, purposely designed to keep in-use insulin cool within safe temperatures of 18-26°C (64.4-78.8°F) for 45 hours minimum, even in a constant environmental temperature of 37.8°C (100°F). The wallet can be 're-activated'/'topped-up' to provide continuous safe storage conditions for subsequent periods of 45 hours minimum for up to 28 days (one month).
Note: 28 days (one month) is the life of in-use insulin. The wallet is re-useable.
Note: insulin must be at the manufacturer's recommended temperature before being placed in the FRIO® wallet. Please check the manufacturer's information leaflet for your specific medication.
For continuous safe storage, the FRIO® inner wallet should be re-immersed in water every 45 hours or sooner if the quantity of gel reduces and starts to return to its crystal form, i.e. crystals can be felt in the panels. When in continuous use, subsequent immersion periods will be shorter as the crystals will be continuously in gel form, i.e. 2-4 minutes will suffice (depending on the size of the wallet).
The FRÍO® has a manufacturer's guarantee of 12 months.
Meanwhile, many of our customers have advised us that their FRÍO® has lasted for several years, but this will depend on how often it is used and how well it is cared for.
Due to varying climatic and environmental conditions around the world, a FRÍO® will respond differently and age accordingly. If activated and used sensibly it will continue to respond to your needs over a long period of time. With age, the length of immersion time will increase but as long as the crystals expand into a gel it will function properly. When the crystals fail to expand, it is time for a replacement.
Note: the FRÍO® is re-usable; the life of 'in-use' insulin is one month.
Yes, FRÍO® wallets can be used for other medications that can be stored at room temperature. We strongly recommend that users of medication other than insulin ask their GP, pharmacist or the medication's manufacturer for the safe travel data/safe travel allowance of their medication.
Note: the wallet does not keep medication as cold as a 'fridge would (2-8°C (35.6-46.4°F)), but it does keep medication cool within safe temperatures of 18-26°C (64.4-78.8°F) for 45 hours minimum, even in a constant environmental temperature of 37.8°C (100°F).
If you would like to check the storage conditions of your medication, please refer to the website www.medicines.org.uk/EMC/ or click on the link where you can access the electronic medical compendium.
Drying Out, Cleaning and Storage
When not in use, remove the inner wallet from the outer cover and allow to completely dry out naturally until the gel returns to crystal form. To keep the crystals separate, give the wallet an occasional shake whilst drying out. Note: the drying out period can take 2-4 weeks depending on the environmental climate.
To accelerate the drying out period, various methods can be used: 1) place near a heat source such as a radiator or in an airing cupboard; 2) hang the wallet on a clothes line if the weather is suitable; 3) leave on a window sill in a sunny position; shaking at intervals will help. DO NOT PLACE THE FRIO® WALLET IN A TUMBLE DRYER!
The outer cover of the wallet can be washed in warm water using a very mild detergent. The inner wallet can be spot cleaned by using a soft bristle brush (i.e. soft toothbrush or nail brush): dip the brush into slightly soapy water and spot clean the wallet. You can then rinse the wallet under running water without damaging the crystals inside. Alternatively, you can use a non-bleach anti-bacterial cleaning spray or an anti-bacterial kitchen or baby wipe to clean your wallet. DO NOT PLACE THE FRIO® WALLET IN A WASHING MACHINE!
Store your FRÍO® wallet in a dry place until you next wish to use it.
These instructions are only a guide. Due to varying climatic and environmental conditions around the world, FRIO® wallets will respond differently according to location. If activated and used sensibly they will continue to respond to your needs over a long period of time. With age, the length of immersion time will increase but as long as the crystals expand into a gel the wallet will function properly. When the crystals fail to expand, the wallet will need to be replaced.
Material Safety Data Sheet (MSDS): the crystals contained in the FRÍO® conform to the relevant British Safety Standards.
To view the MSDS please click on the link - you will then be able to download the file.
FRÍO® TRAVEL WALLETS KEEP INSULIN COOL AND SAFE IN HOT CLIMATES.
We cannot advise you on the use of FRÍO® travel wallets in cold and freezing or other extreme conditions because tests in these conditions have not been carried out.
Any customer testimonials we have received on the use of FRÍO® products in cold and freezing and other extreme temperatures are from individuals who have simply reported back on their use of the wallets in these conditions - we must point out that we cannot recommend the product as safe to use in extreme temperatures or environments.
We can only refer you to our customer Testimonials section.
Our recommendation is that you consult the manufacturer of your medication for advice on insulating insulin and other medication against freezing temperatures.
We recommend that travel plans of more than 4 weeks (one month) are discussed with your Diabetes Specialist Nurse (DSN).
Back from Madagascar now and busily preparing apartments for the fast approaching winter. I just wanted to say a big thank you for your excellent bags for MAD ‘06, our climbing expedition to Madagascar. They were very useful in getting all my insulin safely and coolly delivered to Base Camp.