What is FDA product code OXQ?

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Regard™ · Dressing Change Tray → General Hospital

Name: Regard™
Brand: Regard™

1manufacturer

9catalogue numbers in this listing

2recalls on this code

Who Else Makes It

Registered in Hubei.

Chinese manufacturers registered for FDA product code OXQ
Manufacturer	City	Province	Registered as	Device types
Hubei Lanbin Medical Group Co., Ltd.	Xiaogan	Hubei	Contract manufacturer	33

Record

Regulatory record for Regard™
Listed by	ROi CPS LLC
FDA product code	OXQ
Device type	Dressing Change Tray
Device class	Class 1
Regulation	21 CFR 880.5075
Premarket notification	Exempt
Record published	2019-12-23
Record revised	2022-11-28 (version 4)

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
Label carries	lot or batch number, expiry date
Packaging	Pack of 16, pack of 30, pack of 20, pack of 10
Distribution end date	2025-04-10

Catalogue Numbers

Catalogue numbers for Regard™
Catalogue number	Size	Status
GS00860		Withdrawn
GS00264F		Withdrawn
GS00814B		Withdrawn
GS00814A		Withdrawn
GS00814D		Withdrawn
GS00860B		Withdrawn
GS00264G		Withdrawn
GS00264E		Withdrawn
GS00814C		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	3,005
Medline	Medline Industries, Inc.	1,428
Centurion	Centurion Medical Products Corporation	1,319
Medline Industries, Inc.	Medline Industries, Inc.	218
MedStream	Medical Specialties Distributors, Inc.	202
Vygon	Vygon Corp.	112
LSL Healthcare	Lsl Industries, Inc.	75
Centurion Medical Products Corp	Medline Industries, Inc.	45
ACS	American Contract Systems, Inc.	35
Medline	Centurion Medical Products Corporation	34
Trinity Sterile, Inc.	Trinity Sterile, Inc.	31
DeRoyal	Deroyal Industries, Inc.	15

Showing 12 of 30. All products under Dressing Change Tray

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Regard™
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
ROi CPS LLC	UDI-DI	2023-11-20	Class I	Nonconforming Material/Component	ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.	1830 units	2024-08-05

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	Closed
2021-03-26	Class II	Package design/selection	ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.	272 trays	2023-01-30

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.

Regard™