AccessGUDID - DEVICE: Tourniquet Silicone Cuff; Single Cuff (14250105630104)

GUDID

Device Identifier (DI) Information

Brand Name: Tourniquet Silicone Cuff; Single Cuff
Version or Model: 20-64-611
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VBM Medizintechnik GmbH

Primary DI Number: 14250105630104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 324869601 *Terms of Use
Previous DI: 04250105619799

Device Description: 35 cm / 14 inch

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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 dry, keep away from sunlight and heat

Clinically Relevant Size

[?]

Size Type Text
Length: 35 Centimeter
Length: 14 Inch

Device Record Status

Public Device Record Key: b4db353a-da60-4d2b-9987-da9fe9d62455
Public Version Date: July 05, 2024
Public Version Number: 1
DI Record Publish Date: June 27, 2024