Hillrom powered by Augustine Surgical HD 2083516

GUDID 00850011479582

Temperature Management Controller MP

AUGUSTINE TEMPERATURE MANAGEMENT LLC

Electric pad whole-body heating system Electric pad whole-body heating system Electric pad whole-body heating system Electric pad whole-body heating system Electric pad whole-body heating system
Primary Device ID00850011479582
NIH Device Record Keydbb11009-ba6e-48d7-a953-cbe19e55dfe3
Commercial Distribution StatusIn Commercial Distribution
Brand NameHillrom powered by Augustine Surgical HD
Version Model Number2083516
Catalog Number2083516
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-445-3720
Emailtechnical.support@hillrom.com
Phone800-445-3720
Emailtechnical.support@hillrom.com
Phone800-445-3720
Emailtechnical.support@hillrom.com
Phone800-445-3720
Emailtechnical.support@hillrom.com
Phone800-445-3720
Emailtechnical.support@hillrom.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850011479582 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-25
Device Publish Date2022-05-17

On-Brand Devices [Hillrom powered by Augustine Surgical HD]

00850011479629PST500 Integrated Warming Pad
00850011479612TS7000 Integrated Warming Pad
00850011479605Universal Warming Blanket
00850011479599Lower Body Warming Blanket
00850011479582Temperature Management Controller MP

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