FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756913133
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
89-9357
Catalog number
89-9357
Device description
ARTERIAL LINE TRACEPACK
Published
2021-07-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50749756913138PackageGS140In Commercial Distribution
00749756913133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975691313850749756913138
00749756913133007497569131337497569131330749756913133

GMDN Terms#

Term, Definition table
TermDefinition
Wound dressing kit, medicatedA collection of 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.

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
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756402316DeRoyalNP-6006ULNP-6006UL2026-10-16
00749756402323DeRoyalNP-6007ULNP-6007UL2026-10-16
00749756402330DeRoyalNP-6008ULNP-6008UL2026-10-16
00749756402347DeRoyalNP-0080ULNP-0080UL2026-10-16
00749756402354DeRoyalNP-6014ULNP-6014UL2026-10-16
00749756402361DeRoyalNP-6015ULNP-6015UL2026-10-16
00749756402378DeRoyalNP-6016ULNP-6016UL2026-10-16
00749756402989DeRoyalNP-0250UNP-0250U2026-09-30
00749756402996DeRoyalNP-0450UNP-0450U2026-09-30
00749756403009DeRoyalNP-0450UNNP-0450UN2026-09-30
00749756403016DeRoyalNP-0250UNNP-0250UN2026-09-30
00749756403023DeRoyalNP-0250U-01NP-0250U-012026-09-30
00749756403375DeRoyal31-120P31-120P2026-09-30
00749756369640DeRoyalNP-7000NP-70002026-09-23
00749756389181DeRoyal81-1020SU81-1020SU2026-09-21
00749756389204DeRoyal81-1020REF81-1020REF2026-09-21
00749756399258DeRoyal46-326XBNS46-326XBNS2026-09-21
00749756400442DeRoyal77-40111877-4011182026-09-21
00749756985475DeRoyalNP-790NP-7902026-09-21
00749756985963DeRoyalNP-7300-01NP-7300-012026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956531666CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956565470CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956577374CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956588134CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956593749CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956593756CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10653160393894MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394310MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394426MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394433MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394457MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394556MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394587MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394662MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394679MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394693MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394907MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395072MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395096MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395102MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395218MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395300MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395362MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395379MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395454MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395515MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395522MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395546MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395560MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395638MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14