Regard™
63 catalogue numbers from OB1037, listed by Resource Optimization & Innovation, L.L.C., under Labor And Delivery Kit. 1 manufacturer in China is registered for this product code.
1manufacturer
63catalogue 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 | Resource Optimization & Innovation, L.L.C. |
|---|---|
| FDA product code | MLS |
| Device type | Labor And Delivery Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Premarket notification | Exempt |
| Record published | 2018-03-21 |
| Record revised | 2020-08-27 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| 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 4, pack of 6, pack of 3, pack of 12, pack of 10, pack of 2 |
| Distribution end date | 2020-08-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OB1037 | Withdrawn | |
| OB0985 | Withdrawn | |
| LD0576 | Withdrawn | |
| LD0506 | Withdrawn | |
| OB0819 | Withdrawn | |
| LD1042 | Withdrawn | |
| GY0297 | Withdrawn | |
| LD0629 | Withdrawn | |
| LD0756 | Withdrawn | |
| LD0928 | Withdrawn | |
| GY0770 | Withdrawn | |
| LD0057 | Withdrawn | |
| LD0617 | Withdrawn | |
| LD0547 | Withdrawn | |
| LD0200 | Withdrawn | |
| LD0108 | Withdrawn | |
| LD0866 | Withdrawn | |
| LD0201 | Withdrawn | |
| LD0848 | Withdrawn | |
| LD0631 | Withdrawn | |
| LD0342 | Withdrawn | |
| LD0630 | Withdrawn | |
| LD0306 | Withdrawn | |
| LD0295 | Withdrawn | |
| GY0487 | Withdrawn | |
| GY0284 | Withdrawn | |
| GY0185 | Withdrawn | |
| GY0237 | Withdrawn | |
| LD0861 | Withdrawn | |
| LD0693 | Withdrawn | |
| LD0632 | Withdrawn | |
| GY0488 | Withdrawn | |
| LD0120 | Withdrawn | |
| GY0941 | Withdrawn | |
| LD0526 | Withdrawn | |
| LD0154 | Withdrawn | |
| LD0844 | Withdrawn | |
| LD0081 | Withdrawn | |
| LD0657 | Withdrawn | |
| GY0923 | Withdrawn | |
| LD0269 | Withdrawn | |
| LD0116 | Withdrawn | |
| LD0831 | Withdrawn | |
| LD0589 | Withdrawn | |
| LD0863 | Withdrawn | |
| LD0399 | Withdrawn | |
| LD0596 | Withdrawn | |
| LD0783 | Withdrawn | |
| LD0618 | Withdrawn | |
| LD0481 | Withdrawn | |
| LD0377 | Withdrawn | |
| GY1058 | Withdrawn | |
| LD0518 | Withdrawn | |
| LD0027 | Withdrawn | |
| LD0613 | Withdrawn | |
| GY0811 | Withdrawn | |
| LD0652 | Withdrawn | |
| GY0668 | Withdrawn | |
| LD0044 | Withdrawn | |
| OB0101 | Withdrawn | |
| OB1054 | Withdrawn | |
| GS0387 | Withdrawn | |
| LD0865 | Withdrawn |
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 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 29 |
| 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
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.