AccessGUDID - DEVICE: GSO (06975803530679)

GUDID

Device Identifier (DI) Information

Brand Name: GSO
Version or Model: GDTC3040SD
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Group Supply Organization Medical Technology(Shanghai) Ltd

Primary DI Number: 06975803530679
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 554525912 *Terms of Use

Device Description: Disposable Tourniquet Cuff, Single Bladder, Dual Port, Sterile, Long Leg, 30X4 in

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":	Yes
For Single-Use:	Yes
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?
65141	Arterial tourniquet, pneumatic	An inflatable cuff with fastening mechanism intended to be placed around a patient's limb (arm or leg) and pneumatically inflated from an integrated small gas cartridge to reduce and/or occlude arterial blood circulation to the distal portion of the limb during an emergency situation. It is typically used by emergency medical services (EMS) for emergency blood loss prevention. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KCY	Tourniquet, Pneumatic

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4ad7bd9f-9b93-4535-834d-90e262962efb
Public Version Date: June 19, 2024
Public Version Number: 3
DI Record Publish Date: March 27, 2023