SDR TQH TMT Tourniquet & Holster Set

Basic Information

• Brand Name: SDR TQH TMT Tourniquet & Holster Set
• Primary DI: M689SDRTQH010
• Version / Model: 1
• Catalog Number: SDR TQH TMT
• Company Name: Safeguard US Operating, LLC
• Labeler DUNS: 118492643
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-07
• Public Version: 1
• Public Version Date: 2022-06-15
• Public Version Status: New
• Public Device Record Key: 81b59436-02e8-4d6c-9833-14e88c1b1f49
• Distribution End Date: 9999-06-02

Device Description

31-115 TMT Tourniquet 1 EA L01-003 3x1 blank polypropylene 1 EA L81-000 MARCH Bag Hang Tag 1 EA 89-115-BL TMT Holster Pouch 1 EA

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

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
Primary	M689SDRTQH010	HIBCC