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® Set with Needleless Y Sites - 00818666020153 Catalog Number :

Device Description : 115 in. (290 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

BodyGuard® Microset with Needleless Adaptor - 00818666020160 Catalog Number :

Device Description : 83 in. (210 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 - 00818666020177 Catalog Number :

Device Description : 116 in. (295 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 - 00818666020184 Catalog Number :

Device Description : 90 in. (230 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

BodyGuard® Microset with Filter - 00818666020191 Catalog Number :

Device Description : 85 in. (220 cm) Microset with Filter - yellow stripe, For Use with the BodyGuard 85 in. (220 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

Syringe MicroSet - 00818666020207 Catalog Number :

Device Description : 103 in. (260 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 with Filter - 00818666020214 Catalog Number :

Device Description : 105 in. (270 cm) Microset with Filter - yellow stripe, For Use with the BodyGuar 105 in. (270 cm) Microset with Filter - yellow 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 - 00818666020221 Catalog Number :

Device Description : 134 in. (340 cm) Microset with Filter - Blue Stripe, For Use with the BodyGuard® 134 in. (340 cm) Microset with Filter - 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 w/ 0.2 mic filter and lower y-site with female luer - 00818666020238 Catalog Number :

Device Description : 120 in. (305 cm) Microset with Filter and Y Site - Blue Stripe, For Use with the 120 in. (305 cm) Microset with Filter and Y Site - 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® Syringe Microset - 00818666020245 Catalog Number :

Device Description : 115 in. (290 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

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