Identity
- Trade Name
- bite away FDA UDI
- Generic Name
- Insect bite/sting hyperthermia device FDA UDI
- Device Name
- The bite away® is a handheld device that allows the user to apply a therapeutic dose of heat directly to an insect sting or bite and is clinically proven to provide temporary relief of the resulting itching, pain and swelling. If the device is applied immediately after the sting or bite, the symptoms can usually be prevented completely. Even if the device is used slightly later, the symptoms can still subside sooner. bite away® works solely by concentrated heat and is thus completely free from chemicals (also suitable for pregnant women, allergy sufferers and children). FDA UDI
- Model / Reference
- VI00545 FDA UDI
- Description
- The bite away® is a handheld device that allows the user to apply a therapeutic dose of heat directly to an insect sting or bite and is clinically proven to provide temporary relief of the resulting itching, pain and swelling. If the device is applied immediately after the sting or bite, the symptoms can usually be prevented completely. Even if the device is used slightly later, the symptoms can still subside sooner. bite away® works solely by concentrated heat and is thus completely free from chemicals (also suitable for pregnant women, allergy sufferers and children). FDA UDI
Identifiers
- Catalog Number
- VI00545 FDA UDI
- Primary DI / UDI-DI
- 04260624040295 FDA UDI
- 510(k) Number
- K160943 FDA UDI
- FDA Product Code
- IRT FDA UDI
- GMDN Term
- Insect bite/sting hyperthermia device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Insect bite/sting hyperthermia device
bite away by mibeTec GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Insect bite/sting hyperthermia device.
- iProvèn — Sevenground Trading B.V. · Class II
- Beurer — BEURER NORTH AMERICA, L.P. · Class II
- heat it for iPhone — Kamedi GmbH · Class II
- Beurer — BEURER NORTH AMERICA, L.P. · Class II
- iProvèn — Sevenground Trading B.V. · Class II
- Caring Mill — Caring Mill · Class II
- heat it for Android — Kamedi GmbH · Class II
- heat it classic USB-C — Kamedi GmbH · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- mibeTec GmbH
Sources (1)
- FDA UDI 6d56dc50-2f47-4e78-98b5-251b35916c84 35 fields · synced May 30, 2026