TUR System 0654202

GUDID 20887787006715

LATEX-FREE T-U-R SYSTEM WITH FLOW-POUCH RESERVOIR-2000 mL For Transurethral Resection Procedures For Use With Flexible Container Irrigation System (previously Hospira product)

ICU MEDICAL FLEET SERVICES, LLC

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Primary Device ID20887787006715
NIH Device Record Keyaf9e91dd-f9c1-4adc-9041-629494a6cc68
Commercial Distribution StatusIn Commercial Distribution
Brand NameTUR System
Version Model Number654202
Catalog Number0654202
Company DUNS830767898
Company NameICU MEDICAL FLEET SERVICES, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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(877)946-7747
Emailuscustomercare@icumed.com
Phone+1(877)946-7747
Emailuscustomercare@icumed.com
Phone+1(877)946-7747
Emailuscustomercare@icumed.com
Phone+1(877)946-7747
Emailuscustomercare@icumed.com
Phone+1(877)946-7747
Emailuscustomercare@icumed.com
Phone+1(877)946-7747
Emailuscustomercare@icumed.com
Phone+1(877)946-7747
Emailuscustomercare@icumed.com
Phone+1(877)946-7747
Emailuscustomercare@icumed.com
Phone+1(877)946-7747
Emailuscustomercare@icumed.com
Phone+1(877)946-7747
Emailuscustomercare@icumed.com
Phone+1(877)946-7747
Emailuscustomercare@icumed.com
Phone+1(877)946-7747
Emailuscustomercare@icumed.com
Phone+1(877)946-7747
Emailuscustomercare@icumed.com
Phone+1(877)946-7747
Emailuscustomercare@icumed.com
Phone+1(877)946-7747
Emailuscustomercare@icumed.com

Device Dimensions

Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature. Avoid Excessive Heat. Protect from Freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature. Avoid Excessive Heat. Protect from Freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature. Avoid Excessive Heat. Protect from Freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature. Avoid Excessive Heat. Protect from Freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature. Avoid Excessive Heat. Protect from Freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature. Avoid Excessive Heat. Protect from Freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature. Avoid Excessive Heat. Protect from Freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature. Avoid Excessive Heat. Protect from Freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature. Avoid Excessive Heat. Protect from Freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature. Avoid Excessive Heat. Protect from Freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature. Avoid Excessive Heat. Protect from Freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature. Avoid Excessive Heat. Protect from Freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature. Avoid Excessive Heat. Protect from Freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature. Avoid Excessive Heat. Protect from Freezing
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature. Avoid Excessive Heat. Protect from Freezing

Device Identifiers

Device Issuing AgencyDevice ID
GS110887787006718 [Primary]
GS120887787006715 [Package]
Contains: 10887787006718
Package: case [20 Units]
In Commercial Distribution
HIBCCM3356542020 [Secondary]

FDA Product Code

GBXCATHETER, IRRIGATION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-11
Device Publish Date2018-05-31

Devices Manufactured by ICU MEDICAL FLEET SERVICES, LLC

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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 System2019-12-11LATEX-FREE T-U-R SYSTEM WITH FLOW-POUCH RESERVOIR-2000 mL For Transurethral Resection Procedures For Use With Flexible Container Irrigation System (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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