Regard™
Mercy Standard OB Delivery - RF
1manufacturer
125catalogue numbers in this listing
9recalls on this code
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 | ROi CPS LLC |
|---|---|
| FDA product code | MLS |
| Device type | Labor And Delivery Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Premarket notification | Exempt |
| Record published | 2021-07-22 |
| Record revised | 2021-05-10 (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 | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 6, pack of 4, pack of 3, pack of 10, pack of 2, pack of 16 |
| Distribution end date | 2025-06-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LD00201N | Withdrawn | |
| LD00866C | Withdrawn | |
| LD01180B | Withdrawn | |
| LD01114A | Withdrawn | |
| LD00866E | Withdrawn | |
| GY00770L | Withdrawn | |
| OB01259 | Withdrawn | |
| LD00693D | Withdrawn | |
| GY00284F | Withdrawn | |
| LD00377L | Withdrawn | |
| LD01180A | Withdrawn | |
| LD00081S | Withdrawn | |
| LD00108R | Withdrawn | |
| LD00306E | Withdrawn | |
| LD00081U | Withdrawn | |
| LD00201P | Withdrawn | |
| LD00201O | Withdrawn | |
| GY01058A | Withdrawn | |
| OB01054E | Withdrawn | |
| LD00377J | Withdrawn | |
| LD00201J | Withdrawn | |
| LD00342H | Withdrawn | |
| OB00985C | Withdrawn | |
| LD01117B | Withdrawn | |
| LD01114D | Withdrawn | |
| LD00120P | Withdrawn | |
| LD00154J | Withdrawn | |
| GY01142A | Withdrawn | |
| LD00200O | Withdrawn | |
| LD00865A | Withdrawn | |
| LD00269I | Withdrawn | |
| GY01337 | Withdrawn | |
| OB01054C | Withdrawn | |
| LD00044S | Withdrawn | |
| LD00269G | Withdrawn | |
| LD00928F | Withdrawn | |
| LD00057P | Withdrawn | |
| LD00306D | Withdrawn | |
| LD00201M | Withdrawn | |
| LD00081Q | Withdrawn | |
| LD00865B | Withdrawn | |
| LD00081S | Withdrawn | |
| LD00200L | Withdrawn | |
| GY00923C | Withdrawn | |
| LD01167A | Withdrawn | |
| OB00101Q | Withdrawn | |
| LD00154I | Withdrawn | |
| LD00377O | Withdrawn | |
| LD00027R | Withdrawn | |
| LD01114B | Withdrawn | |
| LD00342D | Withdrawn | |
| OB01317 | Withdrawn | |
| OB01054H | Withdrawn | |
| LD01114E | Withdrawn | |
| LD00865C | Withdrawn | |
| LD00201L | Withdrawn | |
| LD00044Q | Withdrawn | |
| LD01167C | Withdrawn | |
| LD01117C | Withdrawn | |
| LD00108S | Withdrawn | |
| LD01114 | Withdrawn | |
| GY00941B | Withdrawn | |
| LD00377M | Withdrawn | |
| LD00866B | Withdrawn | |
| GY00185K | Withdrawn | |
| LD00027T | Withdrawn | |
| AN01262 | Withdrawn | |
| OB01054F | Withdrawn | |
| GY01058B | Withdrawn | |
| LD00201K | Withdrawn | |
| OB00101O | Withdrawn | |
| LD00116R | Withdrawn | |
| OB00985B | Withdrawn | |
| LD01180 | Withdrawn | |
| LD00108U | Withdrawn | |
| LD00342G | Withdrawn | |
| LD01180C | Withdrawn | |
| OB01054G | Withdrawn | |
| LD00377N | Withdrawn | |
| GY00770K | Withdrawn | |
| GY00284G | Withdrawn | |
| GY00770M | Withdrawn | |
| LD00057Q | Withdrawn | |
| LD01167B | Withdrawn | |
| LD00120Q | Withdrawn | |
| LD01117A | Withdrawn | |
| LD00081R | Withdrawn | |
| GY01338 | Withdrawn | |
| LD00865D | Withdrawn | |
| LD00027Q | Withdrawn | |
| GY01142B | Withdrawn | |
| LD00928E | Withdrawn | |
| GY00923B | Withdrawn | |
| LD00269H | Withdrawn | |
| LD00044R | Withdrawn | |
| LD00342F | Withdrawn | |
| LD01167 | Withdrawn | |
| LD00200M | Withdrawn | |
| OB001010P | Withdrawn | |
| LD00377K | Withdrawn | |
| LD00027S | Withdrawn | |
| LD01117 | Withdrawn | |
| GY00185J | Withdrawn | |
| LD00108Q | Withdrawn | |
| LD00057R | Withdrawn | |
| LD00866D | Withdrawn | |
| LD00200N | Withdrawn | |
| LD01114F | Withdrawn | |
| LD01114C | Withdrawn | |
| OB00101R | Withdrawn | |
| GY01336 | Withdrawn | |
| GS00387F | Withdrawn | |
| GY01142 | Withdrawn | |
| LD00120R | Withdrawn | |
| LD00108P | Withdrawn | |
| OB01054D | Withdrawn | |
| LD00044P | Withdrawn | |
| GY00237O | Withdrawn | |
| OB00985D | Withdrawn | |
| GY00237P | Withdrawn | |
| LD00108T | Withdrawn | |
| LD00116S | Withdrawn | |
| OB01054B | Withdrawn | |
| LD00044N | Withdrawn | |
| LD00377I | 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™ | Resource Optimization & Innovation, L.L.C. | 63 |
| 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
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 | Closed |
|---|---|---|---|---|---|---|---|
| ROi CPS LLC | UDI-DI | 2024-12-26 | Class I | Nonconforming Material/Component | There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of the PIP and PEEP pre | 414 kits | |
| 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. | 70 kits | |
| ROi CPS LLC | UDI-DI | 2021-11-04 | Class II | Process control | The kit contains a non-sterile needle. | 40 kits | 2023-08-07 |
Recalls
6 of these are 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. | 1,501 convenience kits | 2024-08-02 |
| 2021-08-10 | Class II | Nonconforming Material/Component | Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products. | 12 | 2023-06-16 |
| 2021-06-14 | Class II | Process design | Instructions for use updated to include the following cautionary statement for the heel warmer, “Activate away from the user’s face and away from the infant and others.” | 688 units | 2023-03-08 |
| 2021-06-14 | Class II | Process design | Instructions for use updated to include the following cautionary statement for the heel warmer, “Activate away from the user’s face and away from the infant and others.” | 608 units | 2023-03-08 |
| 2021-06-14 | Class II | Process design | Instructions for use updated to include the following cautionary statement for the heel warmer, “Activate away from the user’s face and away from the infant and others.” | 976 units | 2023-03-08 |
| 2020-10-12 | Class II | Labeling Change Control | Labeling error, incorrect expiration date. | 220 kits | 2021-05-13 |
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.