CME AAA-00163

GUDID 08624920003099

T34-Optum Homecare Infusion

OPTUMHEALTH CARE SOLUTIONS, INC.

General-purpose infusion pump, battery-powered
Primary Device ID08624920003099
NIH Device Record Key0dfe5e24-ddb1-4168-bb33-7d7e479293c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameCME
Version Model NumberPump T34OB
Catalog NumberAAA-00163
Company DUNS078270206
Company NameOPTUMHEALTH CARE SOLUTIONS, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108624920003099 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-03
Device Publish Date2020-05-26

Devices Manufactured by OPTUMHEALTH CARE SOLUTIONS, INC.

00862492000353 - Eitan Medical2024-05-02
00862492000308 - Zyno Solutions2020-12-15 Nimbus II-Optum Homecare Infusion
00862492000315 - Portal 7242020-12-15 Optum Home Scale I-Apollo
00862492000322 - Portal 7242020-12-15 Optum Home Scale I-ICUE
00862492000339 - A&D2020-12-15 Optum Home BP I-Apollo
00862492000346 - A&D2020-12-15 Optum Homecare Portal W/BP
08624920003082 - Omron2020-06-03 Optum Homecare LG W/BP
08624920003099 - CME2020-06-03T34-Optum Homecare Infusion
08624920003099 - CME2020-06-03 T34-Optum Homecare Infusion

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