DISPOSA-HOOD

Basic Information

• Brand Name: DISPOSA-HOOD
• Primary DI: H6710305W1
• Version / Model: Large-Wide Hood
• Catalog Number: 0305W
• Company Name: UTAH MEDICAL PRODUCTS, INC.
• Labeler DUNS: 094651270
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 8
• Record Status: Published
• Publish Date: 2020-06-04
• Public Version: 1
• Public Version Date: 2020-06-12
• Public Version Status: New
• Public Device Record Key: f0b6dae7-76e3-4cbd-80c9-f28ec5737638

Device Description

LARGE INFANT OXYGEN HOOD, LARGE-WIDE NECK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
32193	Oxygen administration hood, paediatric	A device consisting of a rigid/semi-rigid transparent plastic shell that forms an enclosure over an infant's whole body, or the head only, in order to provide an enriched environment of oxygen (O2) 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 to be used for patients adverse to oxygen delivery devices such as a nasal cannula or face mask. This device may include the tubing, a diffuser (to disperse the flow of incoming O2), O2 concentration and humidity sensors. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	H6710305W1	HIBCC
Unit of Use	H6710305W0	HIBCC

Customer Contacts

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