ARC Medical

Basic Information

• Brand Name: ARC Medical
• Primary DI: 00810050854115
• Version / Model: 6131M5
• Company Name: TYPENEX MEDICAL LLC
• Labeler DUNS: 600850213
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-26
• Public Version: 1
• Public Version Date: 2021-09-03
• Public Version Status: New
• Public Device Record Key: 7e6cdaf3-ce94-40a1-98ae-ddaa1c79446f

Device Description

circuitGuard® Right Angle Filter, HME & Port,& #5 Mask

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: Yes
• 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: Yes
• 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
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	868.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62128	Patient-end respiratory anaesthesia kit	A collection of non-sterile devices intended to create a hygienic connection between a patient’s airway and an anaesthesia breathing circuit. It is primarily intended for use with a reusable breathing circuit and typically includes an anaesthesia mask, a tube/mask breathing circuit connector and a microbial medical gas filter. This is a single-patient reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810050854115	GS1
Package	10810050854112	GS1	Case	50	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius