Hot Dog Trendelenburg Warming Mattress, 89 cm (35in) U300

GUDID 00855913001985

Labeled: Hot Dog Trendelenburg Warming Mattress, 89 cm (35in) U300

AUGUSTINE TEMPERATURE MANAGEMENT LLC

Electric pad whole-body heating system
Primary Device ID00855913001985
NIH Device Record Key87450c5b-78fd-40fe-97f3-6e89e2c948ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameHot Dog Trendelenburg Warming Mattress, 89 cm (35in)
Version Model NumberU300
Catalog NumberU300
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
GS100855913001985 [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

00855913001817 - HotDog Underbody Warming Mattress + Return Electrode, 82 cm (32")2023-07-25 The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controllin
00855913001824 - HotDog Underbody Warming Mattress + Return Electrode, 127 cm (50")2023-07-25 The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controllin
00850011479100 - WaffleGrip Trendelenburg Positioning Kit + BackSaver Slide Sheet2022-10-18 WaffleGrip Trendelenburg Positioning Kit + Backsaver Slide Sheet, 10 Pack
00850011479506 - WaffleGrip Trendelenburg Positioning Kit for Warming Pad, 10 Pack2022-10-18 WaffleGrip Trendelenburg Positioning Kit + BackSaver Slide Sheet for Warming Pad, 10 Pack
00850011479575 - WaffleGrip2022-10-18 WaffleGrip Disposables for Warming Pad
00850011479636 - WaffleGrip2022-10-18 WaffleGrip Bracket Set
00850011479643 - WaffleGrip PadLock Bracket Set2022-10-18 WaffleGrip PadLock Bracket Set for WaffleGrip Trendelenburg Positioning Kit for Warming Pad
00855913001992 - HotDog Universal Warming Blanket2022-10-18 HotDog Universal Warming Blanket

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