FDA.reportPublic FDA data

FCP-01-GZ

Primary DI
07290017050409
Brand
FCP-01-GZ
Company
FIRST CARE PRODUCTS LTD
Model
FCP-01-GZ
Device description
FCP01, Gauze
Published
2020-09-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
07290017050409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017050409072900170504097290017050409

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

Contacts#

Phone, Email table
PhoneEmail
1-888-737-7978info@ps-med.com

Regulatory Flags#

DUNS number
514694454
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017050485The Quick-T tourniquetQuick-T2024-10-13
07290017050072FCP BandageFCP072020-08-24
07290017050201FCP BandageT3 Military2020-08-26
07290017050225FCP BandageT6 Military2020-08-26
07290017050249FCP Bandage"Gauze 4"""Medical Elastic Wrap 4’’2020-08-26
07290017050096FCP BandageFCP092020-08-25
07290017050102FCP BandageFCP102020-08-25
07290017050119FCP BandageFCP112020-08-25
07290017050126FCP BandageFCP122020-08-25
07290017050133FCP BandageFCP09+2020-08-25
07290017050140FCP BandageFCP10+2020-08-25
07290017050157FCP BandageWoundStop Care1WS-052020-08-25
07290017050164FCP BandageWoundStop HomeCareWS-042020-08-25
07290017050171FCP BandageFCP10T2020-08-25
07290017050188FCP BandageWoundStop Care1+WS-062020-08-25
07290017050010FCP BandageFCP012020-08-24
07290017050027FCP BandageFCP022020-08-24
07290017050034FCP BandageFCP032020-08-24
07290017050058FCP BandageFCP052020-08-24
07290017050065FCP BandageFCP062020-08-24

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