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.

General Hospital › TherapeuticDressing Change Tray

Regard™

Name: Regard™
Brand: Regard™

5 catalogue numbers from GS0313, listed by Resource Optimization & Innovation, L.L.C., under Dressing Change Tray. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

5catalogue numbers in this listing

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	Resource Optimization & Innovation, L.L.C.
FDA product code	OXQ
Device type	Dressing Change Tray
Device class	Class 1
Regulation	21 CFR 880.5075
Premarket notification	Exempt
Record published	2017-11-23
Record revised	2022-11-28 (version 5)

Specifications

Specifications
MRI safety	MR Safe
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 25, pack of 15, pack of 30, pack of 8, pack of 10, pack of 16
Distribution end date	2020-08-26

Catalogue Numbers

Catalogue numbers for Regard™
Catalogue number	Size	Status
GS0313		Withdrawn
GS0264		Withdrawn
GS0834		Withdrawn
GS0860		Withdrawn
GS0814		Withdrawn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

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.