Medline
TRAY,FOLEY,100% SILICONE,16FR,10ML,LF
2manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | PPB |
| Device type | Foley Catheter Kit (Excludes Hiv Testing) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Premarket notification | Exempt |
| Record published | 2016-10-14 |
| Record revised | 2022-06-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10, pack of 12, case of 10 |
| Distribution end date | 2022-03-09 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYND160216S | In distribution | |
| DYK1101835FL | Withdrawn | |
| DYNDL1608 | Withdrawn | |
| DYNDC2072 | Withdrawn | |
| DYK1101835FS | Withdrawn | |
| DYK1101835FM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 343 |
| Dover | Cardinal Health 200, LLC | 6 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 1 |
| Clarity RMS Sensor Tray | RenalSense Ltd. | 1 |
| Cardinal Health | Cardinal Health 200, LLC | 1 |
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.