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) (7) Pump, Breast, Non-Powered (HGY) (3)

Premarket Exempt

No Yes

Clear

Ameda, Inc. - 00810725020494 Catalog Number : 17803LRT

Device Description : Platinum Pump Loaner

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725020524 Catalog Number : 17105

Device Description : Single Short Term HygieniKit STL

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725020548 Catalog Number : 17141

Device Description : One-Hand Pump HygieniKit Adapter (STL)

Device Class : 1

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGY

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725020555 Catalog Number : 17145

Device Description : One-Hand Manual Pump Adapter

Device Class : 1

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGY

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725020579 Catalog Number : 17150

Device Description : Single HygieniKit w/ Manual Adapter (STL)

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725020586 Catalog Number :

Device Description : Single HygieniKit (STL)

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725020593 Catalog Number : 17152

Device Description : Dual HygeiniKit w/ Manual Adapter (STL)

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725020609 Catalog Number : 17153

Device Description : Dual HygieniKit w/ Adapter & Flexishield (STL)

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725020616 Catalog Number : 17155

Device Description : Dual HygieniKit (STL)

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725020647 Catalog Number : 17066P

Device Description : One-Hand Manual Pump w/ Flexishield

Device Class : 1

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGY

Prescription Use : No

Device Count : 1

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