SAVe1 Conversion Kit

Basic Information

• Brand Name: SAVe1 Conversion Kit
• Primary DI: M6892511050020
• Version / Model: 02
• Catalog Number: 25-110-50
• Company Name: Safeguard US Operating, LLC
• Labeler DUNS: 118492643
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-20
• Public Version: 2
• Public Version Date: 2022-04-12
• Public Version Status: Update
• Public Device Record Key: ee2d3b08-5ec0-4e61-94a7-525df7d9fb99

Device Description

Automedx Conversion Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: No
• PM Exempt: No
• 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
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	868.5975	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16803	Ventilator IMV supplemental circuit, single-use	A device designed to provide mandatory breathes to ventilator patients to supplement the spontaneous respiratory rate. It is typically constructed of plastics and consists of tubing and one-way valves. It will be used as an accessory on older ventilators without built-in intermittent mandatory ventilation (IMV) functions. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M6892511050020	HIBCC

Customer Contacts

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