Centurion Medical Products Corp
CHI-STD Vaginal Delivery Pack
1manufacturer
29catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | MLS |
| Device type | Labor And Delivery Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Premarket notification | Exempt |
| Record published | 2023-12-21 |
| Record revised | 2023-07-27 (version 3) |
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 |
| Packaging | Case of 20, case of 5, case of 6, case of 15, case of 3, case of 12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MNS15260 | In distribution | |
| MNS15245 | In distribution | |
| MNS15025 | In distribution | |
| MNS14015 | In distribution | |
| MNS13975 | In distribution | |
| MNS2860A | In distribution | |
| MNS13520 | In distribution | |
| MNS5575A | In distribution | |
| MNS6630C | In distribution | |
| MNS13045 | In distribution | |
| MNS13810 | In distribution | |
| MNS13785A | In distribution | |
| MNS7460A | In distribution | |
| MNS15420 | In distribution | |
| MNS15270A | In distribution | |
| MNS13550 | In distribution | |
| MNS13565 | In distribution | |
| MNS15606 | In distribution | |
| MNS13550A | In distribution | |
| MNS15590 | In distribution | |
| MNS14075 | In distribution | |
| MNS15270 | In distribution | |
| MNS13190 | In distribution | |
| MNS15370 | In distribution | |
| MNS6630B | In distribution | |
| MNS13785 | In distribution | |
| MNS14050 | In distribution | |
| MNS5615A | In distribution | |
| MNS15599 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 3,909 |
| Medline Industries, Inc. | Medline Industries, Inc. | 3,405 |
| ACS | American Contract Systems, Inc. | 244 |
| Centurion | Centurion Medical Products Corporation | 159 |
| Regard™ | ROi CPS LLC | 125 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 63 |
| Aligned Medical Solutions | Aligned Medical Solutions | 16 |
| Medical Action Industries | Medical Action Industries, Inc. | 11 |
| Medline | Medline Industries, Inc. | 6 |
| Halyard | Avid Medical, Inc. | 6 |
| Devon | Cardinal Health | 4 |
| Instrapac | Robinson Healthcare Limited | 4 |
Showing 12 of 16. All products under Labor And Delivery Kit
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Under Investigation by firm | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 27320 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Process control | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 29192 |
| Medline Industries, LP – Northfield | UDI-DI | 2025-03-03 | Class II | Under Investigation by firm | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. | 21935 units |
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.