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) (8) Pump, Breast, Non-Powered (HGY) (2)

Premarket Exempt

No Yes

Clear

Ameda, Inc. - 00810725022467 Catalog Number : 17112

Device Description : Spare Parts Kit

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725022481 Catalog Number : 17189

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. - 00810725022603 Catalog Number : 20001

Device Description : Cord, Platinum, NA

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725022726 Catalog Number : 17064M

Device Description : Ameda Manual Pump

Device Class : 1

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGY

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725022825 Catalog Number : 17608LRTR

Device Description : Elite Breast Pump Loaner Refurb

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725022832 Catalog Number : 17803R

Device Description : Ameda Platinum Pump Refurbished

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725022849 Catalog Number : 17803RTR

Device Description : Ameda Platinum Breast Pump Rental Refurb

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725022856 Catalog Number : 10001

Device Description : Silicone Diaphragm

Device Class :

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 2

Ameda, Inc. - 00810725022863 Catalog Number : 17803LRTR

Device Description : Ameda Platinum Breast Pump Loaner Refurb

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Ameda, Inc. - 00810725022894 Catalog Number : 30001

Device Description : Detachable Power Cord, Elite, Nth America

Device Class : 2

Duns Number: 078719435

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

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