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 Filter - 00818666020009 Catalog Number :

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

Device Class :

Duns Number: 002125419

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

BodyGuard® Microset with Filter - 00818666020016 Catalog Number :

Device Description : 110 in. (280 cm) Microset with Filter - Blue Stripe, For Use with the BodyGuard® 110 in. (280 cm) Microset with Filter - 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 - 00818666020023 Catalog Number :

Device Description : 110 in. (280 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 - 00818666020030 Catalog Number :

Device Description : 94 in. (240 cm) - 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

BodyGuard® Microset - 00818666020047 Catalog Number :

Device Description : 94 in. (240 cm) - 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

BodyGuard® Microset - 00818666020054 Catalog Number :

Device Description : 130 in. (330 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 - 00818666020061 Catalog Number :

Device Description : 83 in. (210 cm) - blue stripe MicroSet 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 - 00818666020122 Catalog Number :

Device Description : 106 in. (269 cm) CMExpress Microbore 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 with Needleless Y-Site - 00818666020139 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

BodyGuard® Microset with Needleless Y-Site - 00818666020146 Catalog Number :

Device Description : 150 in. (380 cm) 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

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