ICU Medical 50131-13

GUDID 00840619085421

Optical Module, Black, OPMOD

ICU MEDICAL FLEET SERVICES, LLC

Cardiac catheterization monitoring system
Primary Device ID00840619085421
NIH Device Record Keye6ee23fe-8329-4b86-aa1b-c4dbf9ba03c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameICU Medical
Version Model Number50131-13
Catalog Number50131-13
Company DUNS830767898
Company NameICU MEDICAL FLEET SERVICES, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)829-9025
Emailcustomerservice@icumed.com
Phone+1(866)829-9025
Emailcustomerservice@icumed.com
Phone+1(866)829-9025
Emailcustomerservice@icumed.com
Phone+1(866)829-9025
Emailcustomerservice@icumed.com
Phone+1(866)829-9025
Emailcustomerservice@icumed.com
Phone+1(866)829-9025
Emailcustomerservice@icumed.com
Phone+1(866)829-9025
Emailcustomerservice@icumed.com
Phone+1(866)829-9025
Emailcustomerservice@icumed.com
Phone+1(866)829-9025
Emailcustomerservice@icumed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840619085421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-03
Device Publish Date2021-08-26

Devices Manufactured by ICU MEDICAL FLEET SERVICES, LLC

00840619085421 - ICU Medical2021-09-03Optical Module, Black, OPMOD
00840619085421 - ICU Medical2021-09-03 Optical Module, Black, OPMOD
10887787009115 - ICU Medical MedNet2020-01-22 Mednet Software
20887787003233 - Plum2019-12-11 Primary PLUM Set 0.2 Micron Filter, CLAVE Secondary Port, CLAVE Y-Site, Secure Lock, 112 Inch (previously Hospira product)
20887787003431 - Plum2019-12-11 Primary PLUM MICRODRIP Set CLAVE Secondary Port, Backcheck Valve, CLAVE Y-Site, Secure Lock, 104 Inch (previously Hospira produc
20887787005015 - Lifeshield2019-12-11 Microbore Extension Set, 10 Inch 0.2 Micron Filter, Prepierced Y-Site, Secure Lock (previously Hospira product)
20887787006715 - TUR System2019-12-11 LATEX-FREE T-U-R SYSTEM WITH FLOW-POUCH RESERVOIR-2000 mL For Transurethral Resection Procedures For Use With Flexible Container
20887787006722 - TUR Set2019-12-11 LATEX-FREE T-U-R Y-Set Nonvented Set for Transurethral Resection Procedures 96 inch (244 cm) For Flexible Irrigation Container S
20887787007248 - Irrigation Set2019-12-11 LATEX-FREE 4-LEAD T-U-R IRRIGATION SET Nonvented Set for Transurethral Resection Procedures 85 inch (216 cm) (previously Hospira

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