Medline Industries, Inc.
Medela KIT
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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | OHH |
| Device type | Breast Pump Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5160 |
| Premarket notification | Exempt |
| Record published | 2021-07-26 |
| Record revised | 2022-06-17 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYKM1036 | In distribution | |
| DYKL1237 | 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 |
| ACS | American Contract Systems, 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.