AccessGUDID - DEVICE: TR BAND (00389701011349)

GUDID

Device Identifier (DI) Information

Brand Name: TR BAND
Version or Model: TRB24-REG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TRB24-REG
Company Name: TERUMO MEDICAL CORPORATION

Primary DI Number: 00389701011349
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131489882 *Terms of Use

Device Description: TR BAND Radial Artery Compression Device

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:	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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Tourniquet cuff, single-use	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 single-use device.

GMDN Preferred Term Name

GMDN Definition

Tourniquet cuff, single-use

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 single-use device.

FDA Product Code

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Product Code	Product Code Name
DXC	CLAMP, VASCULAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152525	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Do not store at extreme temperature or humidity
Special Storage Condition, Specify: Avoid direct sunlight

Clinically Relevant Size

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Size Type Text
Length: 24 Centimeter
Device Size Text, specify: Contents: Regular Band and 25 mL Inflation Syringe

Device Record Status

Public Device Record Key: 26901729-1eae-4364-b0d3-82b56720cca6
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016