FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756194391
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
50-3474
Catalog number
50-3474
Device description
ARTERIAL LINE HYPER TRAY-40/CS
Published
2021-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OXQDressing change tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756194391PackageGS140In Commercial Distribution
00749756194396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975619439150749756194391
00749756194396007497561943967497561943960749756194396

GMDN Terms#

Term, Definition table
TermDefinition
Wound dressing kit, medicated, sterileA collection of sterile instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
50749756401383DeRoyalM60-AP601M60-AP6012026-01-22
50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956336535CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-24
50198956352887CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956352979CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956353198CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956366310CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956375367CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956379686CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956381153CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956401981CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956404739CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-23
50198956351842CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-19
10653160392767Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392774Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392781Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392804Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392811Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392828Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392835Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392842Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392866Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392873Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
10653160392897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-17
50198956348378CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-16
50198956351804CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-16
10653160392699Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-11
10653160392705Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-11
10653160392736Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-11
10653160392743Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-11
10653160392750Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OXQ2026-03-11
50198956297478CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-03-10