FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756040995
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
10-929
Catalog number
10-929
Device description
ST. BURN KIT ADULT SMALL
Published
2023-02-02
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

Product Codes#

Code, Name table
CodeName
OJJBurn kit without drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJJBurn Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756040995PackageGS115In Commercial Distribution
00749756040990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975604099550749756040995
00749756040990007497560409907497560409900749756040990

GMDN Terms#

Term, Definition table
TermDefinition
Burn kit, non-medicatedA collection of devices designed to treat first or second degree burns typically as first aid therapy by emergency medical services (EMS); it does not include pharmaceuticals. It typically includes burn dressings, burn gels, gauze, cold packs, adhesive tapes, and gloves; it may include additional devices such as scissors and masks. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
false
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
false
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
50198956430189CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-03-24
00766588260051Burn Dressing Small - Red Velcro BagCertified Safety Manufacturing, Inc.OJJ2026-03-23
50198956399035CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-03-19
50198956413670CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-03-16
50198956413199CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-03-10
50198956328257CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-02-13
50198956360769CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-02-09
M689SBK1200000030BurnFree Burn Kit 10/CaseSafeguard US Operating, LLCOJJ2026-02-05
50198956306262CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-02-02
50198956270235CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-01-13
50198956307207CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-01-05
50198956254853CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-12-10
50198956251296CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-12-02
50198956217834CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-28
50198956267310CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-28
50198956264166CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-25
50198956218237CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-13
50198956256567CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-13
50198956258523CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-13
50198956259599CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-11
50198956194128CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-09-18
50198956183436CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-09-03
50198956142297CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-08-28
50198956092028CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-08-08
50198956153514CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-08-05
M689FSKHA00020First Responder Food Service Burn Kit 5/CaseSafeguard US Operating, LLCOJJ2025-07-30
40198459418632MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OJJ2025-07-21
50198956137811CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-07-03
50197106928712CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-06-30
50198956119756CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-06-23