Amron Oxygen Treatment Hood

Basic Information

• Brand Name: Amron Oxygen Treatment Hood
• Primary DI: 00860010778616
• Version / Model: 8891-03
• Company Name: Amron International, Inc.
• Labeler DUNS: 086003852
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-30
• Public Version: 1
• Public Version Date: 2025-01-07
• Public Version Status: New
• Public Device Record Key: 0f324e9b-f277-4e00-b6e2-5aebfbc659f2

Device Description

02 VINYL HOOD W/OPTICAL WINDOW, NECK RING ASSEMBLY, UNTRIMMED SILICONE NECK SEAL

Device Characteristics

• Single Use: No
• 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: 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
FOG	Hood, Oxygen, Infant	Anesthesiology	868.5700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45543	Oxygen administration hood, adult	A device consisting of a rigid transparent plastic shell forming an enclosure over the head of an adult, typically to provide an enriched oxygen (O2)environment to increase the patient's O2 uptake. It is connected to an O2 source and may be used concurrently with increased humidification and temperature control. It is designed for a variety of situations: 1) for those adverse to oxygen delivery devices such as a nasal cannula or face mask; 2) for use inside hyperbaric chambers; 3) for specific pulmonary testing. It may include the tubing, a diffuser (to disperse the flow of incoming O2), O2 concentration and humidity sensors, and audio listening facilities. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860010778616	GS1

Customer Contacts

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