CME AMERICA 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) (10)

Premarket Exempt

Clear

BodyGuard® Microset with compression fit adapter - 00818666020252 Catalog Number :

Device Description : 80 in. (200 cm) MicroSet - Green Stripe, For Use with the BodyGuard® Infusion Pump

Device Class : 2

Duns Number: 002125419

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Standard BodySet® with Needleless Connectors - 00818666020269 Catalog Number :

Device Description : 128 in. (320 cm) Microset - Blue Stripe, For Use with the BodyGuard® Infusion Pump

Device Class : 2

Duns Number: 002125419

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

BodyGuard® Microset w/ Non-Vented Spike Connector - 00818666020276 Catalog Number :

Device Description : 130 in. (330 cm) Microset- yellow stripe, For Use with the BodyGuard® Infusion Pump

Device Class : 2

Duns Number: 002125419

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Syringe MicroSet with Filter - 00818666020283 Catalog Number :

Device Description : 110 in. (280 cm) Microset with Filter - yellow stripe, For Use with the BodyGuar 110 in. (280 cm) Microset with Filter - yellow stripe, For Use with the BodyGuard® Infusion Pump

Device Class : 2

Duns Number: 002125419

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

CMExpress® Microbore Set - 00818666020290 Catalog Number :

Device Description : 80 in. (200 cm) Microbore Set - Blue Stripe, For Use with the CMExpress® Infusion Pump

Device Class : 2

Duns Number: 002125419

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

CMExpress® Set with Needleless Y Sites - 00818666020306 Catalog Number :

Device Description : 95 in. (240 cm) Set, For Use with the CMExpress® Infusion Pump

Device Class : 2

Duns Number: 002125419

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

CMExpress® Microbore Set - 00818666020313 Catalog Number :

Device Description : 80 in. (200 cm) Set - Blue Stripe, For Use with the CMExpress® Infusion Pump

Device Class : 2

Duns Number: 002125419

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

CMExpress® Set with Needleless Y Sites - 00818666020320 Catalog Number :

Device Description : 80 in. (200 cm) Microbore Set - Blue Stripe, Spike with Drip Chamber For Use wi 80 in. (200 cm) Microbore Set - Blue Stripe, Spike with Drip Chamber For Use with the CMExpress® Infusion Pump

Device Class : 2

Duns Number: 002125419

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

CMExpress® Needleless Y Site Microbore Set - 00818666020337 Catalog Number :

Device Description : 80 in. (200 cm) Spike with Drip Chamber For Use with the CMExpress® Infusion Pump

Device Class : 2

Duns Number: 002125419

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

CMExpress® Microbore Set with Needleless Y-Site - 00818666020344 Catalog Number :

Device Description : 105 in. (267 cm) CMExpress® Microbore Set w/ Needleless Y-Site For Use with the 105 in. (267 cm) CMExpress® Microbore Set w/ Needleless Y-Site For Use with the CMExpress® Infusion Pump

Device Class : 2

Duns Number: 002125419

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

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