bite away

Primary DI
04260624040295
Brand
bite away
Company
MibeTec GmbH
Model
VI00545
Catalog number
VI00545
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).
Published
2020-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160943000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160943000Bite AwayRiemser Pharma2016-08-26IRT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260624040554PackageGS12In Commercial Distribution
04260624040561PackageGS13In Commercial Distribution
04260624040578PackageGS15In Commercial Distribution
04260624040295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260624040554042606240405544260624040554
04260624040561042606240405614260624040561
04260624040578042606240405784260624040578
04260624040295042606240402954260624040295

GMDN Terms#

Term, Definition table
TermDefinition
Insect bite/sting hyperthermia deviceA portable, battery-powered device intended to be used for the external treatment of insect bites or stings (e.g., from midges/gnats, mosquitoes, wasps, hornets, horseflies) through the application of concentrated heat. The heat (around 50? Celsius) works to minimize or prevent itching, and may prevent subsequent swelling. It typically consists of a pocket-sized, hand-held housing containing electronics, batteries, and a skin-surface contact plate. It is available [non-prescription] over-the-counter (OTC) for home-use. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314579279
Device count
1
Lot or batch
true
Manufacturing date on label
true

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