AccessGUDID - DEVICE: Tourniquet Wipe Cuff, Single Cuff (14250105629078)

GUDID

Device Identifier (DI) Information

Brand Name: Tourniquet Wipe Cuff, Single Cuff
Version or Model: 20-75-727
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VBM Medizintechnik GmbH

Primary DI Number: 14250105629078
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 324869601 *Terms of Use

Device Description: 76 cm / 30 inch

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?
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
Special Storage Condition, Specify: Keep away from sunhight and heat.
Special Storage Condition, Specify: Keep dry.

Clinically Relevant Size

[?]

Size Type Text
Length: 24 Inch
Length: 61 Centimeter

Device Record Status

Public Device Record Key: 96a766df-2c91-4af8-b37f-4a72593d28f7
Public Version Date: August 21, 2023
Public Version Number: 1
DI Record Publish Date: August 11, 2023