Medline
KIT,MIDSTREAM,FUNNEL,BZK,3OZ,CLICK,PREM
7manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (3), Jiangsu (2), Guangdong (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Hangzhou Primecare Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Phase Scientific (Shenzhen) Company Limited | Shenzhen | Guangdong | Repacker / relabeller | 8 |
| Equinox Biotech Co., Ltd. | Shantou | Guangdong | Manufacturer | 5 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | OIE |
| Device type | Urine Collection Kit (Excludes Hiv Testing) |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3250 |
| Premarket notification | Exempt |
| Record published | 2021-08-21 |
| Record revised | 2022-06-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at room temperature. |
| Packaging | Case of 20, case of 40 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYND30215 | In distribution | |
| DYND30212B | In distribution | |
| DYND30212 | In distribution | |
| DYND30211 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medical Action Industries | Medical Action Industries, Inc. | 15 |
| Vacuette | Greiner BIO-ONE Gmbh | 4 |
| Recopad | Medfire Innovations Inc. | 3 |
| Smilereader ovulation test kit | Equinox Biotech Co., Ltd. | 3 |
| David | Equinox Biotech Co., Ltd. | 3 |
| Everlywell Urine Collection Kit | Everly Health, Inc. | 2 |
| Urine Raku-Ryu Cup | Takahashi Keisei Corporation | 2 |
| Therapak | Therapak, LLC | 2 |
| BD Vacutainer Urine Complete Cup Kit | Becton, Dickinson AND Company | 2 |
| SureStep Vacutainer Urine Sampling Kit | C.R. Bard, Inc. | 2 |
| LotFancy | Equinox Biotech Co., Ltd. | 1 |
| DrKea+ | Equinox Biotech Co., Ltd. | 1 |
Showing 12 of 32. All products under Urine Collection Kit (Excludes Hiv Testing)
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.