VACSURE Disposable Tourniquets

GUDID 10850014448339

VACSURE Disposable Tourniquets, TPE Material, 1" x 18" Pre-Notched

LABOTEK GROUP CORP

Venipuncture tourniquet, single-use Venipuncture tourniquet, single-use Venipuncture tourniquet, single-use Venipuncture tourniquet, single-use Venipuncture tourniquet, single-use Venipuncture tourniquet, single-use Venipuncture tourniquet, single-use Venipuncture tourniquet, single-use Venipuncture tourniquet, single-use Venipuncture tourniquet, single-use Venipuncture tourniquet, single-use Venipuncture tourniquet, single-use Venipuncture tourniquet, single-use Venipuncture tourniquet, single-use Venipuncture tourniquet, single-use Venipuncture tourniquet, single-use Venipuncture tourniquet, single-use Venous tourniquet, single-use Venous tourniquet, single-use Venous tourniquet, single-use Venous tourniquet, single-use Venous tourniquet, single-use Venous tourniquet, single-use Venous tourniquet, single-use Venous tourniquet, single-use Venous tourniquet, single-use Venous tourniquet, single-use Venous tourniquet, single-use Venous tourniquet, single-use Venous tourniquet, single-use Venous tourniquet, single-use Venous tourniquet, single-use Venous tourniquet, single-use
Primary Device ID10850014448339
NIH Device Record Key2d745c33-3fb2-4977-96a0-48dd110724c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameVACSURE Disposable Tourniquets
Version Model NumberVS-DTD
Company DUNS117338398
Company NameLABOTEK GROUP CORP
Device Count25
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com
Phone7877851555
Emaile.colon@labotekgroup.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850014448332 [Primary]
GS110850014448339 [Package]
Contains: 00850014448332
Package: Box [25 Units]
In Commercial Distribution
GS120850014448336 [Package]
Package: Case [80 Units]
In Commercial Distribution
GS130850014448333 [Unit of Use]

FDA Product Code

GAXTourniquet, Nonpneumatic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-26
Device Publish Date2024-03-18

Devices Manufactured by LABOTEK GROUP CORP

00850014448141 - VACSURE Uni-Band2024-03-26 VACSURE Uni-Band, Universal bandage, 28 x 15 mm pad size, 19 x 38 mm overall size, Individually wrapped
00850014448165 - Labotek Spot Bandage2024-03-26 Labotek Spot Bandage, 25 mm overall size, Ventilated, Individually wrapped
00850014448189 - TOUCH Chemo Tested Nitrile Exam Glove2024-03-26 TOUCH Nitrile Examination Glove, Chemotherapy Tested, Size X-Small
00850014448202 - TOUCH Chemo Tested Nitrile Exam Glove2024-03-26 TOUCH Nitrile Exam Glove, Chemotherapy Tested, Size Small
00850014448226 - TOUCH Chemo Tested Nitrile Exam Glove2024-03-26 TOUCH Nitrile Examination Glove, Chemotherapy tested, Size Medium
00850014448240 - TOUCH Chemo Tested Nitrile Exam Glove2024-03-26 TOUCH Nitrile Examination Glove, Chemotherapy tested, Size Large
00850014448264 - TOUCH Chemo Tested Nitrile Exam Glove2024-03-26 TOUCH Nitrile Examination Glove, Chemotherapy Tested, Size X-Large
10850014448339 - VACSURE Disposable Tourniquets2024-03-26VACSURE Disposable Tourniquets, TPE Material, 1" x 18" Pre-Notched
10850014448339 - VACSURE Disposable Tourniquets2024-03-26 VACSURE Disposable Tourniquets, TPE Material, 1" x 18" Pre-Notched
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