AccessGUDID - DEVICE: BD Vacutainer® Stretch Tourniquet (30382903672098)

GUDID

Device Identifier (DI) Information

Brand Name: BD Vacutainer® Stretch Tourniquet
Version or Model: 367209
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 367209
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382903672098
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 001292192 *Terms of Use

Device Description: NON-LATEX TOURNIQUET ORANGE ROLL OF 25

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):	No
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 2 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6cb64476-d6e9-4134-b79c-ba3cd59aef48
Public Version Date: June 19, 2024
Public Version Number: 2
DI Record Publish Date: March 13, 2024