FDA.reportPublic FDA data

REXALL HYDROGEL BURN KIT 6PC

Primary DI
06970285515886
Brand
REXALL HYDROGEL BURN KIT 6PC
Company
Shanghai CareUs Medical Product Co., Ltd.
Model
34457701
Published
2022-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OHOFirst Aid Kit Without Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHOFirst Aid Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970285515886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970285515886069702855158866970285515886

GMDN Terms#

Term, Definition table
TermDefinition
Burn gelA substance intended to be applied directly to a minor burn or sunburn to protect against infection, minimize trauma and skin damage, moisten and cool the burn area, and prevent burn progression. It is typically available in sachets, bottles, or spray containers as a gel or spray and is used by emergency medical services (EMS) and critical care units, but may also be used in the home. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545814922
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970285517880CARE-US First Aid Bandages 40CT4097952026-03-27
06970285517897CARE-US First Aid Bandages 40CT4097952026-03-27
06970285517903CARE-US First Aid Bandages 40CT4097952026-03-27
06970285517910CARE-US First Aid Bandages 40CT4097952026-03-27
06970285517293Instant+ reusable gel packMedium2024-09-19
06970285515916REXALL KIDS GEL BEAD COMPRESS 1CT344583012022-07-27
06970285517347Careus3548972025-07-28
06970285517514Careus4097952025-07-10
06970285517521Careus4097952025-07-10
06970285517538Careus4097952025-07-10
06970285517545Careus4097952025-07-10
06970285517552Careus4097952025-07-10
06970285517569Careus4097952025-07-10
06970285517576Careus4097952025-07-10
06970285516586Careus4097952025-07-08
06970285517149Careus4097952025-07-08
06970285517255Careus4097952025-07-08
06970285517385Careus4098202025-06-18
06970285517408Careus4098222025-06-18
06970285517286Weekly pill planner7 Compartments2024-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850070635202TRAUMA RESPONSE KITNar Medical Depot, LLCOHO2026-07-24
M68985205020Mojo Vehicle Rescue Bag - AdvancedSafeguard US Operating, LLCOHO2026-07-22
M68985301040Mojo Vehicle Medical Bag - BasicSafeguard US Operating, LLCOHO2026-07-22
M68985303040Mojo Vehicle Medical Bag - IntermediateSafeguard US Operating, LLCOHO2026-07-22
M6898710003060Individual Trauma Kit - AdvancedSafeguard US Operating, LLCOHO2026-07-22
M6898723101020Bleeding Control KitSafeguard US Operating, LLCOHO2026-07-22
M6898730002040Medical Trauma Kit Shelter in Place (Intermediate)Safeguard US Operating, LLCOHO2026-07-22
M6898730003050Medical Trauma Kit Shelter in Place (Advanced)Safeguard US Operating, LLCOHO2026-07-22
00199972000504CuraplexBOUND TREE MEDICAL, LLCOHO2026-07-17
00842209139255NAR KitNORTH AMERICAN RESCUE, LLCOHO2026-07-06
00842209139262NARNORTH AMERICAN RESCUE, LLCOHO2026-07-06
00842209139279NARNORTH AMERICAN RESCUE, LLCOHO2026-07-06
00842209139286NARNORTH AMERICAN RESCUE, LLCOHO2026-07-06
00842209139293NARNORTH AMERICAN RESCUE, LLCOHO2026-07-06
00842209139231NARNORTH AMERICAN RESCUE, LLCOHO2026-06-22
00842209139248NARNORTH AMERICAN RESCUE, LLCOHO2026-06-22
M689SHSTARTPAXSM030SCHOOL TRAUMA ADVANCED RESPONSE KITSafeguard US Operating, LLCOHO2026-06-22
M689SHSTARTSM030School Trauma Active Response KitSafeguard US Operating, LLCOHO2026-06-22
00049696295260THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
00049696295277THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
00049696295284THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
00049696295291THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
00049696295307THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
00049696295314THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
06953395551029JINGDIJINHUA JINGDI MEDICAL SUPPLIES CO.,LTDOHO2026-06-05
06975675784682Rhino RescueEMSRUN GROUPOHO2026-06-01
06975675788093Rhino RescueEMSRUN GROUPOHO2026-06-01
06975675788109Rhino RescueEMSRUN GROUPOHO2026-06-01
M6898143003020Maritime Boat Box - AdvancedSafeguard US Operating, LLCOHO2026-05-28
00842209138760NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27