ICU MEDICAL FLEET SERVICES, LLC

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

CATHETER, IRRIGATION (GBX) (7) ACCESSORIES, PUMP, INFUSION (MRZ) (3)

Premarket Exempt

No Yes

Clear

Irrigation Set - 10887787006695 Catalog Number : 0653665

Device Description : LATEX-FREE CATHETER IRRIGATION SET, Convertible Pin, 70 Inch (previously Hospira product)

Device Class :

Duns Number: 830767898

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Irrigation Set - 10887787006701 Catalog Number : 0654101

Device Description : LATEX-FREE SECONDARY IRRIGATION SET For Series Hookup For Use with Flexible Cont LATEX-FREE SECONDARY IRRIGATION SET For Series Hookup For Use with Flexible Container Irrigation Systems (previously Hospira product)

Device Class :

Duns Number: 830767898

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

TUR System - 10887787006718 Catalog Number : 0654202

Device Description : LATEX-FREE T-U-R SYSTEM WITH FLOW-POUCH RESERVOIR-2000 mL For Transurethral Rese 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)

Device Class :

Duns Number: 830767898

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

TUR Set - 10887787006725 Catalog Number : 0654301

Device Description : LATEX-FREE T-U-R Y-Set Nonvented Set for Transurethral Resection Procedures 96 i LATEX-FREE T-U-R Y-Set Nonvented Set for Transurethral Resection Procedures 96 inch (244 cm) For Flexible Irrigation Container Systems (previously Hospira product)

Device Class :

Duns Number: 830767898

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Irrigation Set - 10887787006732 Catalog Number : 0654401

Device Description : LATEX-FREE CYSTOSCOPY/IRRIGATION SET Nonvented, 77 inch (195 cm) for Constant or LATEX-FREE CYSTOSCOPY/IRRIGATION SET Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation For Use with Flexible Irrigation Container System (previously Hospira product)

Device Class :

Duns Number: 830767898

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Irrigation Set - 10887787006749 Catalog Number : 0659901

Device Description : LATEX-FREE LARGE BORE Y-IRRIGATION SET Nonvented Set 100 Inch (254 cm) For Flexi LATEX-FREE LARGE BORE Y-IRRIGATION SET Nonvented Set 100 Inch (254 cm) For Flexible Irrigation Container Systems (previously Hospira product)

Device Class :

Duns Number: 830767898

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Irrigation Set - 10887787007241 Catalog Number : 1523901

Device Description : LATEX-FREE 4-LEAD T-U-R IRRIGATION SET Nonvented Set for Transurethral Resection LATEX-FREE 4-LEAD T-U-R IRRIGATION SET Nonvented Set for Transurethral Resection Procedures 85 inch (216 cm) (previously Hospira product)

Device Class :

Duns Number: 830767898

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Sapphire - 10887787007265 Catalog Number : 1632402

Device Description : SAPPHIRE Primary 1.2 Micron Filter Set CLAVE Y-Site, 114 Inch (previously Hospira product)

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

Sapphire - 10887787007272 Catalog Number : 1632502

Device Description : SAPPHIRE Primary 0.2 Micron Filter Set 115 Inch (previously Hospira product)

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

Sapphire - 10887787007302 Catalog Number : 1633202

Device Description : SAPPHIRE Primary 0.2 Micron Filter Set CLAVE Y-Site, 112 Inch (previously Hospira product)

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

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