AccessGUDID - DEVICE: Reusable Conical Cuff (06976514771269)

GUDID

Device Identifier (DI) Information

Brand Name: Reusable Conical Cuff
Version or Model: 24"×4";500-6110
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Zhejiang Longyou Lande Medical Technology Co., Ltd.

Primary DI Number: 06976514771269
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 541228485 *Terms of Use

Device Description: A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit,connecting tubing,and an inflatable cuff.The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.

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):	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?
17230	Tourniquet cuff, reusable	A band-like device that is applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff usually comprises a dual-chamber allowing for alternation of the pressure site to avoid tissue damage or necrosis. This is a reusable 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: No
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: 060abc9c-b148-4bff-946d-7466fd84ee70
Public Version Date: June 02, 2025
Public Version Number: 1
DI Record Publish Date: May 23, 2025