Cardinal Health

WPH Pain Institute Clinic Tray

Registry build 21.09.26
3manufacturers in China registered for this device type
2,332catalogue numbers in this listing
2recalls on this code

Who Else Makes It

Concentrated in Zhejiang (1), Anhui (1), Jiangsu (1).

Chinese manufacturers registered for FDA product code OFQ
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

Regulatory record for Cardinal Health
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

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 numbers for Cardinal Health
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

Other products under the same FDA 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.

Recalls naming the identifiers of Cardinal Health
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.

Recalls referencing this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer