What is FDA product code OHH?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Obstetrics & Gynecology › TherapeuticBreast Pump Kit

Ameda

Name: Ameda
Brand: Ameda

2 catalogue numbers from HygieniKit Plus, listed by Ameda, Inc., United States, under Breast Pump Kit. 4 manufacturers in China are registered for this product code.

Registry build 21.09.26

4manufacturers in China registered for this device type

2catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OHH
Manufacturer	City	Province	Registered as	Device types
SFY Intelligent Technology (Suzhou) Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	3
Avita (Wujiang) Co., Ltd.	Wujiang	Jiangsu	Contract manufacturer	15
Shenzhen Root Innovation Technology Co., Ltd.	Shenzhen	Guangdong	Specification developer	8
Guangdong Youmeng Electrical Technology Co., Ltd.	Foshan	Guangdong	Contract manufacturer	3

Record

Regulatory record for Ameda
Listed by	Ameda, Inc., United States
FDA product code	OHH
Device type	Breast Pump Kit
Device class	Class 2
Regulation	21 CFR 884.5160
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K011519
Record published	2021-04-27
Record revised	2022-11-09 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Over the counter	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Carton of 12

Catalogue Numbers

Catalogue numbers for Ameda
Catalogue number	Size	Status
HygieniKit Plus		In distribution
HygieniKit Plus		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Maymom Double Flange Set for Medela Pump in Style Advanced Pump, 21 mm	Maymom LLC	4
Maymom Double Pumping Kit for Medela Pump in Style Advanced Pump, 30 mm	Maymom LLC	4
Pnsmx Resupply kits	Medela LLC	4
Resupply Kit Swing Maxi/Freestyle Hands-free Pump	Medela LLC	3
Pump In Style® Hands-free Resupply Kit	Medela LLC	3
Medline Industries, Inc.	Medline Industries, Inc.	2
ACS	American Contract Systems, Inc.	2
PersonalFit Flex™ Double Pumping Kit	Medela LLC	2
Symphony Double Pumping Kit	Medela LLC	2
18mm PersonalFit™ Plus Breast shields	Medela LLC	2
Symphony & Harmony Double Duet Breast pump kit-Sterile	Medela LLC	1
Symphony Breastmilk Initiation Kit-Sterile	Medela LLC	1

Showing 12 of 49. All products under Breast Pump Kit

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.