ITL Essentials™ Tourniquet B&B Thick Strap 45cm NS

Basic Information

• Brand Name: ITL Essentials™ Tourniquet B&B Thick Strap 45cm NS
• Primary DI: 19555240404098
• Version / Model: A600001
• Catalog Number: A600001
• Company Name: ITL ASIA PACIFIC SDN. BHD.
• Labeler DUNS: 597723837
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 96
• Record Status: Published
• Publish Date: 2023-12-11
• Public Version: 1
• Public Version Date: 2023-12-19
• Public Version Status: New
• Public Device Record Key: 6231eaee-6b29-4345-bef5-8c18e5e2856d

Device Description

The tourniquet is a constricting band used to control venous and arterial circulation to an extremity for a period of time. The device is for single patient use only.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	878.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35844	Limb tourniquet, manual, reusable	A strap or tubing intended to be wrapped around a patient's limb (arm or leg) and manually tightened to reduce blood circulation to or from the portion of the limb distal to where the device is applied. It is typically used by emergency medical services (EMS) for emergency blood loss prevention or for routine blood sampling. It will typically have a fastening mechanism (e.g., Velcro or a self-locking buckle) that allows adjustments to the degree of tightness. This is a reusable device which may be intended for single- or multi-patient use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	09555240404091	GS1
Primary	19555240404098	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away from Direct Sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry