Cardinal Health
Sterile Women S Mini FFX Tray
3manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Taizhou Xinkang Medical Materials Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 35 |
| Jiangsu Hanheng Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 20 |
| Suzhou Dynarex Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 8 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | OKU |
| Device type | Emergency Obstetrical Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4520 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-01-23 |
| Record revised | 2018-10-22 (version 4) |
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, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case of 4, case of 14, case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SMARPOEHF1 | In distribution | |
| SMA12WMHFD | In distribution | |
| SMA19EMMJC | In distribution | |
| SMARPOEHFB | In distribution | |
| SMA31EOCLB | In distribution | |
| SMA31EOCLC | In distribution | |
| SMARPOEHFA | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Morrison Medical | Morrison Corporation | 16 |
| Curaplex | Bound Tree Medical, LLC | 13 |
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.