BIOS Diagnostics

GUDID 20057475363059

Cooling Gel Patches (4 Pack)

Thermor Ltd

Cold/cool therapy gel Cold/cool therapy gel Cold/cool therapy gel Cold/cool therapy gel Cold/cool therapy gel Cold/cool therapy gel Cold/cool therapy gel Cold/cool therapy gel Cold/cool therapy gel Cold/cool therapy gel Cold/cool therapy gel Cold/cool therapy gel Cold/cool therapy gel Cold/cool therapy gel Cold/cool therapy gel Cold/cool therapy gel
Primary Device ID20057475363059
NIH Device Record Keyc9b255ca-74d0-49dc-995f-5e59e1a594c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOS Diagnostics
Version Model NumberCP305
Company DUNS246883458
Company NameThermor Ltd
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100057475363055 [Primary]
GS110057475363052 [Package]
Package: Case [8 Units]
In Commercial Distribution
GS120057475363059 [Package]
Contains: 00057475363055
Package: Case [3 Units]
In Commercial Distribution

FDA Product Code

OMWAdhesive Backed Thermal Skin Patches

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-18
Device Publish Date2023-12-08

On-Brand Devices [BIOS Diagnostics]

20057475508498Cardiology Stethoscope
80057475507493Deluxe Dual Head Stethoscope
80057475506496Sprague Rappaport Stethoscope
10057475220492Glass Thermometer
20057475363059Cooling Gel Patches (4 Pack)
20057475244105Blood Pressure Monitor/Automatic AFIB

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.