FDA.reportPublic FDA data

Jianyu

Primary DI
06958689900033
Brand
Jianyu
Company
PUJIANG JIANYU SANITARY PRODUCTS COMPANY LTD.
Model
FAK102-B/W
Device description
First Aid Kit
Published
2025-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
06958689900033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06958689900033069586899000336958689900033

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, non-medicated, single-useA convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
541396077
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06958689900002JianyuFAK101-B/W2025-08-09
06958689900026JianyuFAK101-R/B2025-08-09
06958689900040JianyuFAK102-R/B2025-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00842209138777NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27