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 - B101A100164XESF0 Catalog Number :

Device Description : 105 in. (270 cm) - 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® Set with Needleless Y Sites - B101A120003XS2YV0 Catalog Number :

Device Description : 115 in. (290 cm) 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® set with Female Luer - B101A120003XSN0 Catalog Number :

Device Description : 83 in. (210 cm) 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 Needleless Adaptor - B101A120003XSNY0 Catalog Number :

Device Description : 83 in. (210 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 Y-Site - B101A120003XYVA0 Catalog Number :

Device Description : 150 in. (380 cm) 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 - B101A120112XSFK0 Catalog Number :

Device Description : 110 in. (280 cm) - 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

Standard BodySet® with Needleless Connectors - B101A120125XS0 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

Standard BodySet® with Needleless Connectors - B101A120125XSE0 Catalog Number :

Device Description : 128 in. (320 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

CMExpress® Microbore Set - B101A120160C0 Catalog Number :

Device Description : 80 in. (200 cm) 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 - B101A120160C2YRV0 Catalog Number :

Device Description : 95 in. (240 cm) 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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