AMEDA, INC.

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) (10)

Premarket Exempt

No Yes

Clear

Ameda, Inc. - 00810725020005 Catalog Number : 17079M

Device Description : Purely Yours Car Adapter

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725020012 Catalog Number : 17146M

Device Description : Breast Pump Valves - 2 pack

Device Class :

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 2

Ameda, Inc. - 00810725020029 Catalog Number : 17147M

Device Description : Silicone Diaphragms - 2 pack

Device Class :

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 2

Ameda, Inc. - 00810725020036 Catalog Number : 17244M

Device Description : Breast Milk Storage Bottles - 4

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725020043 Catalog Number : 17076PM

Device Description : Cool 'N Carry Tote

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725020067 Catalog Number : 17242M

Device Description : Store 'N Pour Getting Started Kit

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725020074 Catalog Number : 17243M

Device Description : Store 'N Pour Refill Pack - 40

Device Class :

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 40

Ameda, Inc. - 00810725020081 Catalog Number : 17170M

Device Description : Breast Pump Accessory Kit

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725020104 Catalog Number : 17148PM

Device Description : Custom Breast Flanges (Lg/Med)

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725020111 Catalog Number : 17358M

Device Description : Custom Breast Flanges (XXL/XL)

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

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