FDA UDI
In Commercial Distribution
🇺🇸 United States
bite away
DI: 04260624040295
·
Model: VI00545
·
MibeTec GmbH
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- bite away
- Primary DI
- 04260624040295
- Version / Model
- VI00545
- Catalog Number
- VI00545
- Company Name
- MibeTec GmbH
- Labeler DUNS
- 314579279
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-06
- Public Version
- 4
- Public Version Date
- 2021-08-09
- Public Version Status
- Update
- Public Device Record Key
- 6d56dc50-2f47-4e78-98b5-251b35916c84
Device 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).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IRT | Pad, Heating, Powered | Physical Medicine | 890.5740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47103 | Insect bite/sting hyperthermia device | A portable, electrically-powered device intended to be used for the external surface treatment of insect bites or stings (e.g., from midges/gnats, mosquitoes, wasps, hornets, horseflies) through the topical application of concentrated heat. The heat (around 50° Celsius) works to minimize or prevent itching, and may prevent subsequent swelling. It may be either a self-contained hand-held unit or an attachment for a smartphone. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260624040295 | GS1 | ||||
| Package | 04260624040554 | GS1 | 2-pack(Bundl) | 2 | In Commercial Distribution | |
| Package | 04260624040561 | GS1 | 3-pack(Bundl) | 3 | In Commercial Distribution | |
| Package | 04260624040578 | GS1 | 5-pack(Bundl) | 5 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160943 | 000 |