FDA.reportPublic FDA data

Western/Scott Fetzer

Primary DI
B929N4OX600FNNMP40
Brand
Western/Scott Fetzer
Company
Western Enterprises
Model
N4OX-600FNNMP4
Catalog number
N4OX-600FNNMP4
Device description
PKGD: N4-OXY-600-FNN-MP4
Published
2023-01-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B929N4OX600FNNMP40PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen low pressure hoseA length of reinforced colour-coded flexible tubing produced according to ISO5359 intended to conduct compressed oxygen (O2) from an O2 terminal unit or O2 cylinder to a medical device that functions with O2 (e.g., ventilators, anaesthesia unit, analgesia unit, and other O2 dependent respiratory device). The gas pressure in the tubing will be low, a "working pressure" (e.g., 3 - 5 bar), having been reduced by a regulator from a high pressure. The tubing is reinforced with, e.g., woven polyester or cotton and intended for use within a static clinical environment (e.g., intensive care). It is available in various lengths, including standard coil lengths. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-783-7890SALES@WESTERNENTERPRISES.COM

Regulatory Flags#

DUNS number
148634731
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B929C4NI024FNNFP40Western Enterprises, IncC4NI-024FNNFP4C4NI-024FNNFP42026-06-04
B929N4AIK240FHTFP40Western Enterprises, IncN4AIK240FHTFP4N4AIK240FHTFP42026-06-04
B929N4OXW240FHTFP40Western Enterprises, IncN4OXW240FHTFP4N4OXW240FHTFP42026-06-04
B929N4AI096FHTOHF0Western Enterprises, IncN4AI-096FHTOHFN4AI-096FHTOHF2026-05-14
B929N4SU120FNNCHM0Western Enterprises, IncN4SU-120FNNCHMN4SU-120FNNCHM2026-05-06
B929C4AIK072FHTFHT0Western/Scott FetzerC4AIK072FHTFHTC4AIK072FHTFHT2025-11-07
B929C4CO072FP4FNN0Western/Scott FetzerC4CO-072FP4FNNC4CO-072FP4FNN2025-09-23
B929C4OX072FP4OHF0Western/Scott FetzerC4OX-072FP4OHFC4OX-072FP4OHF2025-06-17
B929C4AI096FHTMBA0Western/Scott FetzerC4AI-096FHTMBAC4AI-096FHTMBA2025-05-14
B929C4AI120CHMBLK0Western/Scott FetzerC4AI-120CHMBLKC4AI-120CHMBLK2025-05-14
B929C4OX120CHMBLK0Western/Scott FetzerC4OX-120CHMBLKC4OX-120CHMBLK2025-05-14
B929CROC97920Roberts OxygenCROC-9792CROC-97922025-01-07
B939CROC97910Roberts Oxygen Co. Inc.CROC-9791CROC-97912025-01-07
B929C4OX030FNNMP40Western/Scott FetzerC4OX-030FNNMP4C4OX-030FNNMP42023-01-11
B929N4OX300FP4OHM0Western/Scott FetzerN4OX-300FP4OHMN4OX-300FP4OHM2023-01-07
B929N4OX600FNNBLK0Western/Scott FetzerN4OX-600FNNBLKN4OX-600FNNBLK2023-01-06
B929C4OXW072FNNFP40Western/Scott FetzerC4OXW072FNNFP4C4OXW072FNNFP42024-05-06
B929C4OX012FHTMP20Western/Scott FetzerC4OX-012FHTMP2C4OX-012FHTMP22024-03-08
B929N4OX180OHFOXM0Western/Scott FetzerN4OX-180OHFOXMN4OX-180OHFOXM2024-02-19
B929N4OX192FNNFNN0Western/Scott FetzerN4OX-192FNNFNNN4OX-192FNNFNN2024-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530087142Respiratory AccessorySunset Healthcare Solutions, Inc.BYX2025-11-19
00848530070236CPAP TubingSunset Healthcare Solutions, Inc.BYX2025-05-19
00848530070281CPAP TubingSunset Healthcare Solutions, Inc.BYX2025-05-19
00789091681564Oxygen TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00789091681595CPAP TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00789091681601CPAP TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00848530089375Suction KitSunset Healthcare Solutions, Inc.BYX2025-04-15
00848530094232AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094256AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094263AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094270AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094294AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094317AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094331AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094348AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094355AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094362AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094379AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094386AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094393AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094409AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094416AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094423AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094430AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094447AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094454AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094461AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094478AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094485AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094492AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07