Ameda, Inc. 10005

• FDA 510(k) K011519 decided 15 Aug 2001 Active
• FDA GUDID UDI-DI 00810725023099 listed 24 Sep 2016 Listed

• • Terminated Z-1327-2015 FDA Class II ·initiated 12 Feb 2015 ·on shared 510(k) K011519

  Devices were not sterilized

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 15 Aug 2001 Cleared FDA 510(k) K011519
2. 12 Feb 2015 Recall initiated FDA recalls Z-1327-2015
3. 24 Sep 2016 Listed FDA GUDID 00810725023099

Trade name

Ameda, Inc.

Generic name

Breast pump support kit, single-use

Model / Ref / Catalog

10005

Primary DI / UDI-DI

00810725023099

510(k) Number

K011519 ↗

FDA product code

HGX

GMDN term

Breast pump support kit, single-use

Device class

Class II

Regulation number

884.5160

GUDID distribution status

In Commercial Distribution

Category: Breast pump support kit, single-use

Other devices filed under FDA product code HGX (Pump, Breast, Powered).

• Wearable Breast Pump (Model S21A) by Shenzhen TPH Technology Co., Ltd
• OPERA, OPERA eco by Unimom.Co
• WHITE RIVER AUTOMATIC BREAST PUMP by White River Concepts
• GENTLE EXPRESSIONS ELECTRIC BREAST PUMP by Healthteam
• Electric Breast Pump by Guangdong Horigen Mother & Baby Products Co., Ltd.
• EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP by Evenflo Company, Inc.
• Spectra S3 Plus by UZINMEDICARE CO., LTD
• IVEX MODEL NO. BP 3000 BREASTPUMP by Ivex Medical, Inc.
• THE WHITE RIVER PORTA-ELEC-BREAST PUMP by Natural Technologies, Inc.
• RUMBLE TUFF by Acute Ideas Co., Ltd.

• Ameda, Inc. 17148PM

  Class II

  FDA 510(k) K011519 Active Cleared 15 Aug 2001 GUDID on market

• Ameda, Inc 10004

  Class II

  FDA 510(k) K011519 Active Cleared 15 Aug 2001 GUDID on market

• Ameda, Inc. 17115

  Class II

  FDA 510(k) K011519 Active Cleared 15 Aug 2001 GUDID on market

• Ameda, Inc. 10002

  Class II

  FDA 510(k) K011519 Active Cleared 15 Aug 2001 GUDID on market

See all devices from Ameda, Inc. →