AMEDA, INC.

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

Pump, Breast, Powered (HGX) (9) Breast Pump Kit (OHH) (1)

Premarket Exempt

No Yes

Clear

Ameda, Inc. - 00810725023167 Catalog Number : 10014

Device Description : 30.5mm Breast Flange

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725023174 Catalog Number : 80001

Device Description : Locking Ring and Disc

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda - 00810725025062 Catalog Number : 131A40

Device Description : Double Electric Breast Pump

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda - 00810725025079 Catalog Number : 131A41

Device Description : Double electric breast pump with large tote

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda - 00810725025086 Catalog Number : 131W50

Device Description : Double Electric Breast Pump

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda - 00810725025093 Catalog Number : 131W51

Device Description : Double Electric Breast Pump with Tote

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda - 00810725025444 Catalog Number : 17452

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : OHH

Prescription Use : No

Device Count : 1

Ameda - 00810725025574 Catalog Number : 132A04

Device Description : Double electric breast pump

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda - 00810725025581 Catalog Number : 132A05

Device Description : Double electric breast pump with tote bag

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda - 00810725025598 Catalog Number : 132A06

Device Description : Double electric breast pump with deluxe edition accessories and spare parts

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

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