PFIZER INC.

Address:100 Route 206 North,Peapack,NJ,07977,US

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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

Calculator/data processing module, for clinical use (JQP) (1) PACK, HOT OR COLD, DISPOSABLE (IMD) (1) Syringe, piston (FMF) (1)

Premarket Exempt

No Yes

Clear

ThermaCare ColdWraps - 00305733041024 Catalog Number :

Device Description : THERMACARE COLDWRAPS JOINT THERAPY 1CT

Device Class : 1

Duns Number: 079625650

Premarket Exempt : Yes

Product Code : IMD

Prescription Use : No

Device Count : 1

wtATTR-CM AcceleraTTR™ - 05415062388310 Catalog Number :

Device Description : Software to identify heart failure patients who may be at risk of having wtATTR-CM

Device Class : 1

Duns Number: 829076566

Premarket Exempt : Yes

Product Code : JQP

Prescription Use : No

Device Count : 1

Genotropin Mixer® - 10300130923796 Catalog Number :

Device Description : The Genotropin Mixer is a device used to mix growth hormone that is provided in The Genotropin Mixer is a device used to mix growth hormone that is provided in a Two-Chamber Cartridge (TCC). The Genotropin Mixer is a non-sterile, reusable medical device designed for mixing the Genotropin TCC.

Device Class : 2

Duns Number: 829076566

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

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