FDA.reportPublic FDA data

DISPOSA-HOOD

Primary DI
H67103131
Brand
DISPOSA-HOOD
Company
UTAH MEDICAL PRODUCTS, INC.
Model
Extra Large Hood
Catalog number
0313
Device description
EXTRA LARGE INFANT OXYGEN HOOD
Published
2020-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FOGHood, Oxygen, Infant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOGHood, Oxygen, InfantAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H67103131PrimaryHIBCC0
H67103130Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen administration hood, paediatricA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-533-4984customer@utahmed.com

Regulatory Flags#

DUNS number
094651270
Device count
6
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H671303TT0CMITender Touch Cup303TT2016-09-23
H671303TTL0CMITender Touch Cup303TTL2016-09-23
H671404TT0CMITender Touch Cup404TT2016-09-23
H67141828050UMBILI-CATHSingle-Lumen Polyurethane41828052016-09-23
H67141835050UMBILI-CATHSingle-Lumen Polyurethane41835052016-09-23
H67141850050UMBILI-CATHSingle-Lumen Polyurethane41850052016-09-23
H67141865050UMBILI-CATHSingle-Lumen Polyurethane41865052016-09-23
H67142828050UMBILI-CATHDual-Lumen Polyurethane42828052016-09-23
H67142835050UMBILI-CATHDual-Lumen Polyurethane42835052016-09-23
H67142850050UMBILI-CATHDual-Lumen Polyurethane42850052016-09-23
H67143850050UMBILI-CATHTriple-Lumen Polyurethane43850052016-09-23
H671444FC0CMIFlex Cup444FC2016-09-23
H671505TT0CMIUltra Cup505TT2016-09-23
H671505TTL0CMIUltra Cup505TTL2016-09-23
H671506TTL0CMIUltra Cup506TTL2016-09-23
H671600TT0CMISecure Cup600TT2016-09-23
H671606TT0CMISecure Cup606TT2016-09-23
H671IUP4000INTRANPlusIUP-4002016-09-23
H671IUP4500INTRANPlusIUP-4502016-09-23
H671IUP5000INTRANPlusIUP-5002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010778616Amron Oxygen Treatment HoodAmron International, Inc.FOG2024-12-30
00850052737009Sea-Long Medical HoodSea-Long Medical Systems LLCFOG2024-11-21
00860010778609Amron Oxygen Treatment HoodAmron International, Inc.FOG2023-08-10
B366U1VNI1001ECLERIS NIV HELMETEclerisFOG2022-06-30
H67103001DISPOSA-HOODUTAH MEDICAL PRODUCTS, INC.FOG2020-06-04
H67103011DISPOSA-HOODUTAH MEDICAL PRODUCTS, INC.FOG2020-06-04
H67103021DISPOSA-HOODUTAH MEDICAL PRODUCTS, INC.FOG2020-06-04
H67103051DISPOSA-HOODUTAH MEDICAL PRODUCTS, INC.FOG2020-06-04
H6710305W1DISPOSA-HOODUTAH MEDICAL PRODUCTS, INC.FOG2020-06-04
H67103081DISPOSA-HOODUTAH MEDICAL PRODUCTS, INC.FOG2020-06-04
H67103141DISPOSA-HOODUTAH MEDICAL PRODUCTS, INC.FOG2020-06-04
00350770928081Bite BlockAvanos Medical, Inc.FOG2020-02-05
00350770928098AVANOSAvanos Medical, Inc.FOG2020-02-05