Hot Dog Multi-Position Warming Blanket B105

GUDID 00855913001381

Labeled Hot Dog Multi-Position Warming Blanket B105

AUGUSTINE TEMPERATURE MANAGEMENT LLC

Electric pad whole-body heating system
Primary Device ID00855913001381
NIH Device Record Key9b989ab1-4c84-44c7-aa06-81fe02af6fe8
Commercial Distribution StatusIn Commercial Distribution
Brand NameHot Dog Multi-Position Warming Blanket
Version Model NumberB105
Catalog NumberB105
Company DUNS965879187
Company NameAUGUSTINE TEMPERATURE MANAGEMENT LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone952-746-1720
Emailcs@augbiomed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100855913001381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWJSystem, Thermal Regulating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-28

Devices Manufactured by AUGUSTINE TEMPERATURE MANAGEMENT LLC

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