Sechrist Industries, Inc.

Basic Information

• Brand Name: Sechrist Industries, Inc.
• Primary DI: 00899660002871
• Version / Model: 20558-00
• Company Name: SECHRIST INDUSTRIES, INC.
• Labeler DUNS: 062084215
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-01
• Public Version: 2
• Public Version Date: 2024-01-24
• Public Version Status: Update
• Public Device Record Key: 2b77f64e-4f0e-48c8-a925-3705da6cc797

Device Description

AIR BREAK BREATHING APPARATUS, ENGLISH, DEMAND FLOW

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBP	Valve, Non-Rebreathing	Anesthesiology	868.5870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17169	Demand valve	A non-sterile device that is used to regulate the therapeutic gas flow to a patient in response to the patient's breathing effort. It is used, e.g., in ventilator breathing circuits, resuscitation devices and in on demand analgesia devices. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00899660002871	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K884543	000