AccessGUDID - DEVICE: VACSURE Disposable Tourniquets (00850014448332)

GUDID

Device Identifier (DI) Information

Brand Name: VACSURE Disposable Tourniquets
Version or Model: VS-DTD
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LABOTEK GROUP CORP

Primary DI Number: 00850014448332
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 117338398 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
67048	Venous tourniquet, single-use	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAX	Tourniquet, Nonpneumatic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 50 and 95 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2d745c33-3fb2-4977-96a0-48dd110724c4
Public Version Date: June 19, 2024
Public Version Number: 2
DI Record Publish Date: March 18, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10850014448339	25	00850014448332		In Commercial Distribution	Box
20850014448336	80	10850014448339		In Commercial Distribution	Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 30850014448333 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 7877851555
Email: e.colon@labotekgroup.com

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