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) Breast Pump Kit (OHH) (1) Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic (MGQ) (1) Pump, Breast, Non-Powered (HGY) (1)

Premarket Exempt

No Yes

Clear

Ameda, Inc. - 00810725021699 Catalog Number : 17603

Device Description : Elite Breast Pump Refurb

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725021705 Catalog Number : 17003

Device Description : Elite Breast Pump Refurb

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725021804 Catalog Number : 17508RT

Device Description : Elite Breast Pump w/ 9ft Cord Refurb

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725021828 Catalog Number : 17605

Device Description : Elite Breast Pump

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725021835 Catalog Number : 17608

Device Description : Elite Breast Pump 2 Prong

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725021873 Catalog Number : 17510LRT

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. - 00810725022276 Catalog Number : 17264

Device Description : ComfortGel HydroGel Pads (Bulk)

Device Class :

Duns Number: 078719435

Premarket Exempt : Yes

Product Code : MGQ

Prescription Use : No

Device Count : 2

Ameda, Inc. - 00810725022351 Catalog Number : 17060

Device Description : OHBP w/ STD Flange

Device Class : 1

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGY

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725022399 Catalog Number : 17158

Device Description : Dual HygieniKit wAdap ST

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda - 00810725022405 Catalog Number : 17451

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : OHH

Prescription Use : No

Device Count : 1

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