FDA.reportPublic FDA data

VACSURE Disposable Tourniquets

Primary DI
00850014448332
Brand
VACSURE Disposable Tourniquets
Company
LABOTEK GROUP CORP
Model
VS-DTD
Device description
"VACSURE Disposable Tourniquets, TPE Material, 1"" x 18"" Pre-Notched"
Published
2024-03-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAXTourniquet, Nonpneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850014448339PackageGS125In Commercial Distribution
20850014448336PackageGS180In Commercial Distribution
00850014448332PrimaryGS10
30850014448333Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001444833910850014448339
2085001444833620850014448336
00850014448332008500144483328500144483320850014448332
3085001444833330850014448333

GMDN Terms#

Term, Definition table
TermDefinition
Venous tourniquet, single-useA device in the form of a narrow band or strap intended to be wrapped and manually tightened typically around a patient's arm to control/stop blood flow during collection of blood from a vein; it may additionally be used with a pressure bandage to apply pressure to a wound. It typically includes an adherent layer (e.g., Velcro) and/or a buckle mechanism for fastening/locking that allows adjustments to the degree of tightness; it is not fastened via a rotating handle mechanism (i.e., not a windlass). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit95 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
7877851555e.colon@labotekgroup.com

Regulatory Flags#

DUNS number
117338398
Device count
25
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014448424VacSure EZ Care Pressure Activate Safety LancetVEZC-30152024-12-03
00850014448431VacSure EZ Care Pressure Activate Safety LancetVEZC-30152024-12-03
00850014448462VacSure EZ Care Pressure Activate Safety LancetVEZC-21222024-12-03
00850014448134VACSURE Uni-BandRR-1512024-03-18
00850014448158Labotek Spot BandageRR-1502024-03-18
00850014448172TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-XS2024-03-18
00850014448196TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-S2024-03-18
00850014448219TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-M2024-03-18
00850014448233TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-L2024-03-18
00850014448257TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-XL2024-03-18
00850014448349VACSURE Sharp ContainerRRI-1QT2024-03-18
00850014448356VACSURE Sharp ContainerRRI-5QT2024-03-18
00850014448363VACSURE Sharp ContainerRRI-2GAL2024-03-18
00850014448370VACSURE Sharp ContainerRRI-3GAL-S2024-03-18
00850014448387VACSURE Sharp ContainerRRI-8GAL2024-03-18
00850014448141VACSURE Uni-BandRR-1512024-03-18
00850014448165Labotek Spot BandageRR-1502024-03-18
00850014448189TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-XS2024-03-18
00850014448202TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-S2024-03-18
00850014448226TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-M2024-03-18

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Primary DI, Brand, Company table
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