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. - 00810725020807 Catalog Number : 617802

Device Description : Purely Yours Pump

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725020814 Catalog Number : 617804

Device Description : Purely Yours Ultra

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725020821 Catalog Number : 17085MT

Device Description : Purely Yours Ultra Pump

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725020906 Catalog Number : 17071

Device Description : Purely Yours Breast Pump

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725020999 Catalog Number : 17086

Device Description : Purely Yours Ultra Breast Pump

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725021170 Catalog Number : 17510RT

Device Description : Elite Breast Pump w/ 9ft Cord

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725021620 Catalog Number : 17115

Device Description : Dual HygieniKit (STL)

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda - 00810725021644 Catalog Number : 17077MT

Device Description : Purely Yours Carry All Breast Pump

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725021668 Catalog Number : 17243MT

Device Description : Store 'N Pour Milk Storage Bages (50 count + 2 adapters)

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725021675 Catalog Number : 17070ACA

Device Description : Purely Yours with Bag

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

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