ICU MEDICAL FLEET SERVICES, LLC

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Filters

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

Set, administration, intravascular (FPA) (5) ACCESSORIES, PUMP, INFUSION (MRZ) (4) Infusion safety management software (PHC) (1)

Premarket Exempt

No Yes

Clear

Plum - 10887787008804 Catalog Number : 1427329

Device Description : Primary PLUM MICRODRIP 150 mL Burette Set, CLAVE Additive Port, 2 CLAVE Y-Sites, Primary PLUM MICRODRIP 150 mL Burette Set, CLAVE Additive Port, 2 CLAVE Y-Sites, Secure Lock, 114 Inch (previously Hospira product)

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

ICU Medical MedNet - 10887787009115 Catalog Number : 160379201

Device Description : Mednet Software

Device Class : 2

Duns Number: 830767898

Premarket Exempt : No

Product Code : PHC

Prescription Use : No

Device Count : 1

Blood Set - 10887787009146 Catalog Number : 1273002

Device Description : Primary Y-Type Blood Set 200 Micron Filter, Bulb Pump, Prepierced Y-Site, Secure Primary Y-Type Blood Set 200 Micron Filter, Bulb Pump, Prepierced Y-Site, Secure Lock, 80 Inch (previously Hospira product)

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Plum - 10887787009214 Catalog Number : 2400601

Device Description : PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore T PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 107 Inch

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Plum - 10887787009221 Catalog Number : 2400701

Device Description : PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore T PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, 107 Inch

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Sapphire - 10887787009238 Catalog Number : 2400801

Device Description : SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 117 Inch

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

Sapphire - 10887787009245 Catalog Number : 2401501

Device Description : SAPPHIRE Epidural Set with NRFit Connector Non-Vented, Yellow-Striped Microbore, SAPPHIRE Epidural Set with NRFit Connector Non-Vented, Yellow-Striped Microbore, PAV, 118 Inch

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

Sapphire - 10887787009252 Catalog Number : 2401001

Device Description : SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, 119 Inch

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

Sapphire - 10887787009269 Catalog Number : 2401301

Device Description : SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

Primary Sets - 10887787009276 Catalog Number : B917801

Device Description : PRIMARY SET CLAVE Y-Site, 100 Inch, Non-DEHP

Device Class :

Duns Number: 830767898

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

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