ARC Adjustable Radial Cuff

Basic Information

• Brand Name: ARC Adjustable Radial Cuff
• Primary DI: 00811331011340
• Version / Model: RCB-0048
• Company Name: Tz Medical, Inc.
• Labeler DUNS: 793149709
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2023-11-15
• Public Version: 1
• Public Version Date: 2023-11-23
• Public Version Status: New
• Public Device Record Key: a512b3c4-c67b-4f42-9601-dd574f642bb7

Device Description

ARC Adjustable Radial Cuff- Medium

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
58704	Radial artery compression device	A device intended to provide compression for haemostasis to the puncture site on a patient having undergone radial artery catheterization, and can be used as an alternative to direct hand pressure. It typically consists of one or more pad/strap(s), which may also have a compression/decompression knob and a time indicator; it may be applied so that it does not compress the ulna artery or block venous return. It is typically used following coronary angiography/ventriculography or percutaneous transluminal coronary angioplasty (PTCA). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00811331011333	GS1
Primary	00811331011340	GS1

Premarket Submissions

Submission Number	Supplement Number
K040208	000