AccessGUDID - DEVICE: ITL Essentials™ Tourniquet B&B Thick Strap 45cm NS (19555240404098)

GUDID

Device Identifier (DI) Information

Brand Name: ITL Essentials™ Tourniquet B&B Thick Strap 45cm NS
Version or Model: A600001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A600001
Company Name: ITL ASIA PACIFIC SDN. BHD.

Primary DI Number: 19555240404098
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 96
Labeler D-U-N-S® Number*: 597723837 *Terms of Use

Device Description: The tourniquet is a constricting band used to control venous and arterial circulation to an extremity for a period of time. The device is for single patient use only.

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:	No
Prescription Use (Rx):	Yes
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?
67047	Venous tourniquet, reusable	A device in the form of a narrow 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 reusable device which might be intended for single-patient use.	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
Special Storage Condition, Specify: Keep Away from Direct Sunlight
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6231eaee-6b29-4345-bef5-8c18e5e2856d
Public Version Date: November 12, 2024
Public Version Number: 2
DI Record Publish Date: December 11, 2023