TR Band

Basic Information

• Brand Name: TR Band
• Primary DI: 36927675519888
• Version / Model: TRB29-LRG
• Catalog Number: TRB29-LRG
• Company Name: Terumo Medical Products (Hangzhou) Co., Ltd.
• Labeler DUNS: 544830912
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2024-09-01
• Public Version: 1
• Public Version Date: 2024-09-09
• Public Version Status: New
• Public Device Record Key: 96a32298-cc71-4669-9766-0c8a2ef28226

Device Description

TR Band Radial Artery Compression Device

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXC	Clamp, Vascular	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35925	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	56927675519882	GS1	carton	4	In Commercial Distribution
Primary	36927675519888	GS1
Unit of Use	06927675519887	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	290	Millimeter
Device Size Text, specify			Belt LENGTH:29CM

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid exposure to water, direct sunlight, extreme temperature, or high humidity during storage.