bite away VI00545

GUDID 04260624040295

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).

MibeTec GmbH

Insect bite/sting hyperthermia device

• Primary Device ID: 04260624040295
• NIH Device Record Key: 6d56dc50-2f47-4e78-98b5-251b35916c84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: bite away
• Version Model Number: VI00545
• Catalog Number: VI00545
• Company DUNS: 314579279
• Company Name: MibeTec GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260624040295 [Primary]
GS1	04260624040554 [Package]; Package: 2-pack(Bundl) [2 Units]; In Commercial Distribution
GS1	04260624040561 [Package]; Package: 3-pack(Bundl) [3 Units]; In Commercial Distribution
GS1	04260624040578 [Package]; Package: 5-pack(Bundl) [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160943

FDA Product Code

• IRT: Pad, Heating, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-14
• Device Publish Date: 2020-02-06