Sea-Long Medical Hood

Basic Information

• Brand Name: Sea-Long Medical Hood
• Primary DI: 00850052737009
• Version / Model: 500 Seris Model
• Company Name: Sea-Long Medical Systems LLC
• Labeler DUNS: 622106151
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-21
• Public Version: 1
• Public Version Date: 2024-11-29
• Public Version Status: New
• Public Device Record Key: 91c26827-c1b1-4a83-bd3f-710ff0b32425

Device Description

5000 Series Helmet

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ultraviolet Light

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FOG	HOOD, OXYGEN, INFANT	Anesthesiology	868.5700	1
CBF	Chamber, hyperbaric	Anesthesiology	868.5470	2

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	00850052737009	GS1

Customer Contacts

• Phone: [phone] ext. 3
• Email: [email protected]