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) (8) Pump, Infusion (FRN) (2) Pump, Infusion, Pca (MEA) (2)

Premarket Exempt

Clear

500ml Lock Box Kit - B101190900PXCV0 Catalog Number :

Device Class : 2

Duns Number: 002125419

Premarket Exempt : No

Product Code : MEA, FRN

Prescription Use : Yes

Device Count : 1

500ml Ultimate Lockbox - B101190900PXCVP0 Catalog Number :

Device Description : Lockbox compatible with bags up to 500 mL, syringes 20 mL to 60 mL, and bottles Lockbox compatible with bags up to 500 mL, syringes 20 mL to 60 mL, and bottles up to 50 mm in diameter (1), keys (2), Instructions for Use (1).

Device Class : 2

Duns Number: 002125419

Premarket Exempt : No

Product Code : FRN, MEA

Prescription Use : Yes

Device Count : 1

BodyGuard® Microset - B101A100163XE90S0 Catalog Number :

Device Description : 90 in. (230 cm) - yellow stripe, For Use with the BodyGuard® Pump

Device Class : 2

Duns Number: 002125419

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

BodyGuard® Microset with Male Luer Connectors - B101A100163XEBF0 Catalog Number :

Device Description : 130 in. (330 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® Microset w/ Non-Vented Spike Connector - B101A100163XEBS0 Catalog Number :

Device Description : 130 in. (330 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® Microset - B101A100163XES0 Catalog Number :

Device Description : 94 in. (240 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® Microset with Filter - B101A100163XESF0 Catalog Number :

Device Description : 85 in. (220 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® Microset - B101A100163XESV0 Catalog Number :

Device Description : 94 in. (240 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

Syringe MicroSet with Filter - B101A100163XSFL0 Catalog Number :

Device Description : ~110 in. (280 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

Syringe MicroSet - B101A100163XSL0 Catalog Number :

Device Description : 103 in. (260 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

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