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.

DeRoyal · Dressing Change Tray → General Hospital

Name: DeRoyal
Brand: DeRoyal

1manufacturer

15catalogue numbers in this listing

1recall

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 DeRoyal
Listed by	Deroyal Industries, Inc., United States
FDA product code	OXQ
Device type	Dressing Change Tray
Device class	Class 1
Regulation	21 CFR 880.5075
Establishment	Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2021-07-09
Record revised	2022-11-28 (version 2)

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	Labelled latex-free
Label carries	lot or batch number, expiry date
Packaging	Case of 50, case of 20, case of 40, case of 10, case of 15
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for DeRoyal
Catalogue number	Size	Status
89-7959		In distribution
47-709		In distribution
89-7071		In distribution
47-401		In distribution
89-9357		In distribution
47-757		In distribution
47-670		In distribution
47-686		In distribution
89-9470		In distribution
89-10797		In distribution
10-6506		In distribution
10-6475		In distribution
47-483		In distribution
50-3474		In distribution
89-10811		In distribution

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
Medical Action Industries	Medical Action 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 DeRoyal
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Deroyal Industries, Inc.	UDI-DI	2022-03-03	Class II	Process control	A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.	400 kits	2022-09-15

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.

DeRoyal