Duns Number:314579279
Device Description: The bite away® is a handheld device that allows the user to apply a therapeutic dose of he 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).
Catalog Number
VI00545
Brand Name
bite away
Version/Model Number
VI00545
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160943,K160943,K160943,K160943
Product Code
IRT
Product Code Name
Pad, Heating, Powered
Public Device Record Key
6d56dc50-2f47-4e78-98b5-251b35916c84
Public Version Date
August 09, 2021
Public Version Number
4
DI Record Publish Date
February 06, 2020
Package DI Number
04260624040554
Quantity per Package
2
Contains DI Package
04260624040295
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
2-pack(Bundl)