TR BAND TRB24-REG

GUDID 50389701011344

TR BAND Radial Artery Compression Device

TERUMO MEDICAL CORPORATION

Tourniquet cuff, single-use

• Primary Device ID: 50389701011344
• NIH Device Record Key: 26901729-1eae-4364-b0d3-82b56720cca6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TR BAND
• Version Model Number: TRB24-REG
• Catalog Number: TRB24-REG
• Company DUNS: 131489882
• Company Name: TERUMO MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 24 Centimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature or humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00389701011349 [Primary]
GS1	30389701011340 [Package]; Contains: 00389701011349; Package: Shelfbox [5 Units]; In Commercial Distribution
GS1	50389701011344 [Package]; Contains: 30389701011340; Package: Carton [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152525

FDA Product Code

• DXC: CLAMP, VASCULAR

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [TR BAND]

• 50389701011351: TR BAND Radial Artery Compression Device
• 50389701011344: TR BAND Radial Artery Compression Device
• 00389701012476: TR BAND Radial Artery Compression Device
• 00389701012469: TR BAND Radial Artery Compression Device