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

ACCESSORIES, PUMP, INFUSION (MRZ) (10)

Premarket Exempt

No Yes

Clear

Sapphire - 10887787007319 Catalog Number : 1633503

Device Description : SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch (previously Hospira product)

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

Sapphire - 10887787007357 Catalog Number : 1636202

Device Description : SAPPHIRE Primary 0.2 Micron Filter Set Microbore, CLAVE Y-Site, 118 Inch (previo SAPPHIRE Primary 0.2 Micron Filter Set Microbore, CLAVE Y-Site, 118 Inch (previously Hospira product)

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

Sapphire - 10887787007364 Catalog Number : 1636302

Device Description : SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, 119 Inch (pre SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, 119 Inch (previously Hospira product)

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

Sapphire - 10887787007395 Catalog Number : 1637201

Device Description : SAPPHIRE Non-Vented PCA Set KVO Y-Extension, Microbore, PAV, 115 Inch (previousl SAPPHIRE Non-Vented PCA Set KVO Y-Extension, Microbore, PAV, 115 Inch (previously Hospira product)

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

Sapphire - 10887787007401 Catalog Number : 1637302

Device Description : SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch (previously Hospira product)

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

Sapphire - 10887787007418 Catalog Number : 1637402

Device Description : SAPPHIRE Epidural Set Non-Vented, Yellow-Striped Microbore, PAV, 118 Inch (previ SAPPHIRE Epidural Set Non-Vented, Yellow-Striped Microbore, PAV, 118 Inch (previously Hospira product)

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

Sapphire - 10887787007425 Catalog Number : 1638102

Device Description : SAPPHIRE Primary Set Non-Vented, Microbore, PAV, 118 Inch (previously Hospira product)

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

Sapphire - 10887787007432 Catalog Number : 1638303

Device Description : SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch (previously Hospira product)

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

Sapphire - 10887787007449 Catalog Number : 1638401

Device Description : SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch (pre SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch (previously Hospira product)

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

Sapphire - 10887787007470 Catalog Number : 1638802

Device Description : SAPPHIRE Primary Set 119 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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