Cardinal Health
WPH Pain Institute Clinic Tray
Who Else Makes It
Concentrated in Zhejiang (1), Anhui (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Anhui Medpurest Medical Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 46 |
| Changzhou Rongxin Medicine Minimal Invasion Technology Co., Ltd. | Jintan | Jiangsu | Contract manufacturer | 10 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | OFQ |
| Device type | Anesthesia Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5120 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-02-04 |
| Record revised | 2022-06-17 (version 6) |
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, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case of 20, case of 10, case of 30, case of 12, case of 25, case of 24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SBA95SCDU3 | In distribution | |
| 34-0084C | In distribution | |
| 34-6102F | In distribution | |
| 34-6885G | In distribution | |
| SBA69PTSM4 | In distribution | |
| 34-2082C | In distribution | |
| 13-4454D | In distribution | |
| 34-0818C | In distribution | |
| 17-8541A | In distribution | |
| 34-8304J | In distribution | |
| SBA40PMAS4 | In distribution | |
| 13-0582F | In distribution | |
| SBACNPTMR5 | In distribution | |
| 34A2424A | In distribution | |
| 13-3398B | In distribution | |
| 13-2176 | In distribution | |
| SBA56PPSN1 | In distribution | |
| 34-4392G | In distribution | |
| 34-3103B | In distribution | |
| 34A4087D | In distribution | |
| ANECG6385D | In distribution | |
| 34A4663A | In distribution | |
| 13-8880A | In distribution | |
| 34-0678E | In distribution | |
| 13A5770E | In distribution | |
| 13-4277F | In distribution | |
| 34-5256B | In distribution | |
| 34-0062B | In distribution | |
| 34-4449A | In distribution | |
| 34-9532B | In distribution | |
| 34-6505B | In distribution | |
| 13-6814D | In distribution | |
| 13A3955D | In distribution | |
| 34-4430B | In distribution | |
| 34-4520H | In distribution | |
| SBACGPAEAD | In distribution | |
| 34-4950A | In distribution | |
| 13-4475A | In distribution | |
| 34-2051C | In distribution | |
| SMA33PPSF5 | In distribution | |
| 34-4520E | In distribution | |
| SAN26IPMHB | In distribution | |
| SBA41PNTHE | In distribution | |
| 34-4520C | In distribution | |
| 34A8853E | In distribution | |
| 34A1656J | In distribution | |
| 34-3286A | In distribution | |
| 34-6652A | In distribution | |
| 34-8331A | In distribution | |
| 34-5857P | In distribution | |
| 13-5034A | In distribution | |
| SBA69PPSR1 | In distribution | |
| 34-8880A | In distribution | |
| 34-6400A | In distribution | |
| SBACGPASCA | In distribution | |
| 34-8354A | In distribution | |
| 34-0019A | In distribution | |
| 34-2477C | In distribution | |
| 34-3933I | In distribution | |
| SBA40PPBMA | In distribution | |
| 34-4826C | In distribution | |
| SAN56LPZE5 | In distribution | |
| 34-1354C | In distribution | |
| SBA69PTAPD | In distribution | |
| 34-4663A | In distribution | |
| 34-9642B | In distribution | |
| 34-0611C | In distribution | |
| 34-2656O | In distribution | |
| SBACNPEMC7 | In distribution | |
| SBA40PNCF1 | In distribution | |
| 17-3410A | In distribution | |
| 27-2537H | In distribution | |
| 34-8463B | In distribution | |
| 34-9054E | In distribution | |
| SBAOCPMDSA | In distribution | |
| 34-5849A | In distribution | |
| 13-4132A | In distribution | |
| 34-3110A | In distribution | |
| 34-7831C | In distribution | |
| SAN26IPMHF | In distribution | |
| 34-7573C | In distribution | |
| 34-7576B | In distribution | |
| 34-8060E | In distribution | |
| 34-6672C | In distribution | |
| 34A8314A | In distribution | |
| ANE378147E | In distribution | |
| 34-6582E | In distribution | |
| 34-8701F | In distribution | |
| 34-1746A | In distribution | |
| SBA43IPIC3 | In distribution | |
| 34-4537C | In distribution | |
| 34-5983A | In distribution | |
| SBA41PPBHD | In distribution | |
| 13-5065G | In distribution | |
| 34-8304C | In distribution | |
| 34-6134B | In distribution | |
| 34-7301A | In distribution | |
| 34-9616D | In distribution | |
| 34-0917F | In distribution | |
| 34-0097H | In distribution | |
| 34-6582O | In distribution | |
| 13-6266B | In distribution | |
| 34-7111B | In distribution | |
| SAN95SCD12 | In distribution | |
| 34-0892A | In distribution | |
| 34B0096A | In distribution | |
| 34-6672B | In distribution | |
| 34-1774D | In distribution | |
| 34-9936C | In distribution | |
| 34-2713B | In distribution | |
| SBA29PNCCD | In distribution | |
| 34-4464A | In distribution | |
| 34-6288D | In distribution | |
| 13-3700C | In distribution | |
| SBA40PPBBA | In distribution | |
| 13-3700B | In distribution | |
| 34-8304D | In distribution | |
| SBACGPAEA1 | In distribution | |
| 34-1746B | In distribution | |
| 13A9028C | In distribution | |
| 34-1453A | In distribution | |
| SNE41EPPR9 | In distribution | |
| 13-1537D | In distribution | |
| ANE415034A | In distribution | |
| 34-5078A | In distribution | |
| 34-4405C | In distribution | |
| 34-6400C | In distribution | |
| 34-0500F | In distribution | |
| 34-4229A | In distribution | |
| 34-5857L | In distribution | |
| 34A5387K | In distribution | |
| 34-3586A | In distribution | |
| 34B0641C | In distribution | |
| 34-6288C | In distribution | |
| 34-6741D | In distribution | |
| 34-3584F | In distribution | |
| 34A5387P | In distribution | |
| SBAHFPPSDA | In distribution | |
| SBA41PPBHA | In distribution | |
| 34-2341D | In distribution | |
| 34-6921G | In distribution | |
| 34-7271D | In distribution | |
| 05-7723E | In distribution | |
| 13-6344B | In distribution | |
| 34-3800A | In distribution | |
| 34A2053E | In distribution | |
| 34-9143G | In distribution | |
| SBAHDPMM10 | In distribution | |
| 34-2428B | In distribution | |
| 34-0062F | In distribution | |
| 34A5387H | In distribution | |
| SBA56LPZEA | In distribution | |
| SBA44ASUTA | In distribution | |
| 17-0342 | In distribution | |
| 34B3195B | In distribution | |
| 34-1774F | In distribution | |
| SBA29BCSGA | In distribution | |
| 34-1279A | In distribution | |
| SBA48PPADB | In distribution | |
| 34B3195D | In distribution | |
| 13-1723L | In distribution | |
| 13-5043C | In distribution | |
| SBA23PPSM2 | In distribution | |
| SBA7IPROUE | In distribution | |
| 34-6301A | In distribution | |
| 34-7304L | In distribution | |
| SBA42PKSL5 | In distribution | |
| 34-4430J | In distribution | |
| 34-3584A | In distribution | |
| 34-4725C | In distribution | |
| 34-5226O | In distribution | |
| 34-2423A | In distribution | |
| 26-3700A | In distribution | |
| 34-0957I | In distribution | |
| 34-3666B | In distribution | |
| 34-2280A | In distribution | |
| 13-8391B | In distribution | |
| 34-2656R | In distribution | |
| 34-5274A | In distribution | |
| 34-9317G | In distribution | |
| 34-8094C | In distribution | |
| 34-1410P | In distribution | |
| SBA3MCPCVB | In distribution | |
| 17-4921A | In distribution | |
| 34-4088A | In distribution | |
| SBA13MNMRO | In distribution | |
| 34-7483C | In distribution | |
| 34-5169A | In distribution | |
| SBA69PPSRA | In distribution | |
| SBACGPLACB | In distribution | |
| 34-4875E | In distribution | |
| 34-0257C | In distribution | |
| 34-8545A | In distribution | |
| 13-6590A | In distribution | |
| 34-8038F | In distribution | |
| 17-4553D | In distribution | |
| 34-4583A | In distribution | |
| 34-3933C | In distribution | |
| 34-7304K | In distribution | |
| 34-2967B | In distribution | |
| 34-2656J | In distribution | |
| 34-5538F | In distribution | |
| 34-6582D | In distribution | |
| 34A8541E | In distribution | |
| 34-3217B | In distribution | |
| 34-7077B | In distribution | |
| 34-3847D | In distribution | |
| AN1428752E | In distribution | |
| 34-4826I | In distribution | |
| ANE3781472 | In distribution | |
| SBA36PMSCE | In distribution | |
| 34A3928A | In distribution | |
| 34-1125B | In distribution | |
| 34-0292A | In distribution | |
| SBAHFPTASB | In distribution | |
| 34-5851A | In distribution | |
| 34A4087C | In distribution | |
| 34-0919F | In distribution | |
| 34A4532A | In distribution | |
| SMA33PPSFC | In distribution | |
| SBAHDPMM35 | In distribution | |
| 17-2899 | In distribution | |
| 34-3085B | In distribution | |
| SBA29PPWSB | In distribution | |
| SBAHDPMUV1 | In distribution | |
| 34-1109E | In distribution | |
| 34-5889A | In distribution | |
| 34-0950C | In distribution | |
| SBA44PPWB5 | In distribution | |
| 34-1125A | In distribution | |
| 17-8308D | In distribution | |
| SBA40PNCFC | In distribution | |
| SBACGPAEAA | In distribution | |
| SBA11APJM1 | In distribution | |
| 13-8038B | In distribution | |
| SPPV1PPFS3 | In distribution | |
| 34-9410A | In distribution | |
| 34-4875D | In distribution | |
| 34-4857C | In distribution | |
| 34-1279D | In distribution | |
| 34-2072C | In distribution | |
| 34-5489A | In distribution | |
| 34-2950B | In distribution | |
| 34-2482F | In distribution | |
| SBAOCPMDS2 | In distribution | |
| 34A1656A | In distribution | |
| SMA33PPSFB | In distribution | |
| SAN95SCDU1 | In distribution | |
| 34-3584E | In distribution | |
| 34-9988D | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 54 |
| ambIT | Summit Medical Products, Inc. | 34 |
| ACS | American Contract Systems, Inc. | 21 |
| ambIT* | Avanos Medical, Inc. | 19 |
| Stradis Healthcare | Stradis Healthcare | 11 |
| Stradis | Stradis Healthcare | 9 |
| Henry Schein | Henry Schein, Inc. | 6 |
| Invenio | GRI-Alleset, Inc. | 2 |
| ambIT* Cassette – Filter, Spike | Avanos Medical, Inc. | 2 |
| ambIT* Cassette – Filter, Spike with Yellow Striped Tubing | Avanos Medical, Inc. | 2 |
| Continuous Regional Anesthesia Kit | Custom Interventional Pain Management | 2 |
| ambIT* Military PCA Pump | Avanos Medical, Inc. | 1 |
Showing 12 of 22. All products under Anesthesia Kit
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cardinal Health 200, LLC | UDI-DI | 2023-08-16 | Class II | Material/Component Contamination | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). | 13,351 total packs |
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 |
|---|---|---|---|---|
| 2026-07-14 | Class II | Nonconforming Material/Component | Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products. | 456 kits |
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.