BE 1000-2 O2 Instant Flow Valve Bag Hanger

Basic Information

• Brand Name: BE 1000-2 O2 Instant Flow Valve Bag Hanger
• Primary DI: M996BE100020
• Version / Model: BE 1000-2
• Catalog Number: BE 1000-2
• Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED
• Labeler DUNS: 053146767
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-31
• Public Version: 2
• Public Version Date: 2019-07-12
• Public Version Status: Update
• Public Device Record Key: 022854cf-a6dc-454b-adee-c393d78be8c4

Device Description

BE 1000-2 Bag Hanger mates with arm of O2 Instant Flow Valve to support a resuscitation bag. This is an accessory to the BE 3000 Series Oxygen Instant Flow Valves. Reusable.

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Ethylene Oxide", "Radiation Sterilization", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	868.5915	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37498	Respiratory oxygen therapy system	An assembly of devices designed to be interconnected to administer oxygen (O2) to a patient using various methods of oxygen administration (e.g., face mask, nasal canula) at different concentrations (e.g., via a gas mixer), duration of use, and flows. It will connect to an oxygen source and will typically include a flowmeter or flow controlling device, masks, tubing, valves, and/or nasal cannulae. It can also include, e.g., a high pressure gas reduction valve(s) and a pneumatically-powered suction device with collection bottle.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M996BE100020	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K970959	000