AMEDA, INC.

Address:485 Half Day Road,Buffalo Grove,IL,60089,US

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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

Pump, Breast, Non-Powered (HGY) (1) Pump, Breast, Powered (HGX) (1)

Premarket Exempt

No Yes

Clear

Ameda - 00810725025772 Catalog Number : 132W12

Device Description : Double Electric Breast Pump with Tote Bag, Cooler Bag and Manual Pump

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda - 00810725025826 Catalog Number : 18001

Device Description : Dual milk collection system

Device Class : 1

Duns Number: 078719435

Premarket Exempt : Yes

Product Code : HGY

Prescription Use : No

Device Count : 1

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