FDA.reportPublic FDA data

Ptensys Bleeding Control Station

Primary DI
00855204008020
Brand
Ptensys Bleeding Control Station
Company
TyTek Medical Inc.
Model
TM-400
Catalog number
TM-400
Device description
Ptensys Bleeding Control Station
Published
2019-10-03
Public version status
Update
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
00855204008020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855204008020008552040080208552040080200855204008020

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
078589992
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010987902Surgical HypoHolder10032025-06-27
00860010987940Clinical HypoHolder10042025-06-27
00860010987926HypoPan10092025-06-17
00860013471606HypoFoam10002025-06-17
00855204008006TPAKTM-303TM-3032019-10-03
00855204008013TVACTM-909TM-9092019-10-03
00855204008037Ptensys Bleeding Control KitsTM-401TM-4012019-10-03
00855204008051TPAKTM-310TM-3102019-10-03
00855204008068TYTEK TRAUMA BANDAGETM-204TM-2042019-10-03
00855204008075TYTEK TRAUMA BANDAGETM-206TM-2062019-10-03
00855204008082TYTEK TRAUMA BANDAGETM-212TM-2122019-10-03
00855204008099EZ GAUZETM-215TM-2152019-10-03
00855204008167PneumoDartTM-317TM-3172019-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850056748742Pacific BiomedicalINTEGRATED MEDCRAFT LLCOHO2026-07-31
00850056748735Pacific BiomedicalINTEGRATED MEDCRAFT LLCOHO2026-07-30
M6898723101030Bleeding Control KitSafeguard US Operating, LLCOHO2026-07-30
M6898810501060Patrol Officer IFAK BasicSafeguard US Operating, LLCOHO2026-07-27
M6898810502060Patrol Officer IFAK IntermediateSafeguard US Operating, LLCOHO2026-07-27
M6898810503070Patrol Officer IFAK AdvancedSafeguard US Operating, LLCOHO2026-07-27
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