Regard™
C Section Supplemental Bundle
3manufacturers in China registered for this device type
78catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Anhui (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Anhui Medical Sterilizing Co., Ltd. | Hefei | Anhui | Contract manufacturer | 8 |
Record
| Listed by | ROi CPS LLC |
|---|---|
| FDA product code | OHM |
| Device type | Cesarean Section Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1720 |
| Premarket notification | Exempt |
| Record published | 2022-02-17 |
| Record revised | 2025-05-20 (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 | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 2, pack of 3, pack of 4, pack of 25 |
| Distribution end date | 2026-01-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LD01002F | Withdrawn | |
| LD00358H | Withdrawn | |
| LD00056U | Withdrawn | |
| OB01168 | Withdrawn | |
| LD00846A | Withdrawn | |
| LD00019P | Withdrawn | |
| LD00692E | Withdrawn | |
| LD00911D | Withdrawn | |
| LD00911B | Withdrawn | |
| LD00199S | Withdrawn | |
| LD00028R | Withdrawn | |
| LD00427O | Withdrawn | |
| LD00358N | Withdrawn | |
| LD00056R | Withdrawn | |
| LD01002E | Withdrawn | |
| LD00199N | Withdrawn | |
| LD00911G | Withdrawn | |
| LD00427K | Withdrawn | |
| LD00427L | Withdrawn | |
| LD00226L | Withdrawn | |
| LD00226K | Withdrawn | |
| OB00100Z | Withdrawn | |
| LD00358O | Withdrawn | |
| LD00990 | Withdrawn | |
| OB00100X | Withdrawn | |
| OB00100AA | Withdrawn | |
| LD00156L | Withdrawn | |
| LD00019R | Withdrawn | |
| LD00358P | Withdrawn | |
| LD00274I | Withdrawn | |
| LD00312D | Withdrawn | |
| LD00427R | Withdrawn | |
| LD00427M | Withdrawn | |
| OB01168A | Withdrawn | |
| LD00028P | Withdrawn | |
| LD00042Q | Withdrawn | |
| LD00056T | Withdrawn | |
| LD00274G | Withdrawn | |
| LD00028Q | Withdrawn | |
| LD01002C | Withdrawn | |
| LD00156M | Withdrawn | |
| OB00100W | Withdrawn | |
| LD00358I | Withdrawn | |
| LD00042P | Withdrawn | |
| LD00090T | Withdrawn | |
| LD00199O | Withdrawn | |
| LD00056S | Withdrawn | |
| LD00358L | Withdrawn | |
| OB00100AB | Withdrawn | |
| LD00358J | Withdrawn | |
| LD00427P | Withdrawn | |
| LD00199Q | Withdrawn | |
| LD00109P | Withdrawn | |
| LD00358K | Withdrawn | |
| LD00056V | Withdrawn | |
| LD00312F | Withdrawn | |
| LD00358M | Withdrawn | |
| LD00090S | Withdrawn | |
| LD01002CD | Withdrawn | |
| LD00911E | Withdrawn | |
| OB00100Y | Withdrawn | |
| LD00846C | Withdrawn | |
| LD00312E | Withdrawn | |
| LD00911C | Withdrawn | |
| LD00199R | Withdrawn | |
| LD00199P | Withdrawn | |
| LD00427N | Withdrawn | |
| LD00019Q | Withdrawn | |
| LD00846B | Withdrawn | |
| LD00846D | Withdrawn | |
| LD00090U | Withdrawn | |
| LD00090R | Withdrawn | |
| LD00427Q | Withdrawn | |
| LD00028S | Withdrawn | |
| LD00042R | Withdrawn | |
| LD00274H | Withdrawn | |
| LD00109Q | Withdrawn | |
| LD00911F | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 7,091 |
| Medline Industries, Inc. | Medline Industries, Inc. | 5,487 |
| ACS | American Contract Systems, Inc. | 533 |
| DeRoyal | Deroyal Industries, Inc. | 32 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 32 |
| Medline | Medline Industries, Inc. | 7 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 6 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 6 |
| Aligned Medical Solutions | Aligned Medical Solutions | 3 |
| Henry Schein | Henry Schein, Inc. | 2 |
| Halyard | Avid Medical, Inc. | 2 |
| Invenio | GRI-Alleset, Inc. | 1 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ROi CPS LLC | UDI-DI | 2023-03-22 | Class II | Nonconforming Material/Component | The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component. | 1,312 kits | |
| ROi CPS LLC | UDI-DI | 2022-06-03 | Class II | Process change control | Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits. | 40 kits | 2023-04-14 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-03-18 | Class II | Nonconforming Material/Component | A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture. | 290 convenience kits | 2024-08-02 |
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.