ACS
Breast Pump 355071 NON-Sterile
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.
| 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
| Listed by | American Contract Systems, Inc. |
|---|---|
| FDA product code | OHH |
| Device type | Breast Pump Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5160 |
| Premarket notification | Exempt |
| Record published | 2021-07-21 |
| Record revised | 2022-06-17 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MEPU25A | In distribution | |
| MEPU25B | In distribution |
Same 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 |
| PersonalFit Flex™ Double Pumping Kit | Medela LLC | 2 |
| Ameda | Ameda, Inc. | 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.