andorate® Single Use Tourniquet

Basic Information

• Brand Name: andorate® Single Use Tourniquet
• Primary DI: 14897106953667
• Version / Model: GAR007
• Company Name: GA Health Company Limited
• Labeler DUNS: 686908512
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-12
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 4378413d-0357-48a2-b347-b7ebb7210443

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
58128	Limb tourniquet, manual, single-use	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 typically does not include latex and may be available in a variety of designs (e.g., Velcro or a self-locking buckle, synthetic rubber band). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24897106953664	GS1	Carton	1000	In Commercial Distribution
Primary	14897106953667	GS1