FDA.reportPublic FDA data

Ohio

Primary DI
00628101632502
Brand
Ohio
Company
OHIO MEDICAL, LLC
Model
HS-13U2-DFXXC4
Catalog number
HS-13U2-DFXXC4
Device description
"13' HOSE ASMBLY N20 DF*XX COND 1/4"""
Published
2026-05-13
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00628101632502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628101632502006281016325026281016325020628101632502

GMDN Terms#

Term, Definition table
TermDefinition
Nitrous oxide low pressure hose"A length of reinforced colour-coded flexible tubing produced according to ISO5359 intended to conduct compressed nitrous oxide (N2O) from an N2O terminal unit or N2O cylinder to a medical device that functions with N2O (e.g., ventilator, anaesthesia unit, analgesia unit, or other N2O dependent medical 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."

Contacts#

Phone, Email table
PhoneEmail
+1(847)855-6218customer.service@ohiomedical.com

Regulatory Flags#

DUNS number
005192885
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628101620387OhioGR-CS-PA-01001GR-CS-PA-010012026-05-18
00628101620837OhioGR-CS-AS-01001GR-CS-AS-010012026-05-18
00628101620851OhioGR-MU-00101GR-MU-001012026-05-18
00628101632618OhioAM-TH300440AM-TH3004402026-05-18
00628101632625OhioGR-F4OGR-F4O2026-05-18
00628101632496Ohio HS-13IV-DFXXC4 HS-13IV-DFXXC42026-05-13
00628101632557Ohio HS-01UW-CFCMC4 HS-01UW-CFCMC42026-05-13
00628101632472OhioHS-15UV-F2CMC4HS-15UV-F2CMC42026-05-06
00628101632519OhioHS-20UO-DEOEC4HS-20UO-DEOEC42026-05-06
00628101632526Ohio HS-20UA-DAOEC4 HS-20UA-DAOEC42026-05-06
00628101632540OhioHS-25UI-DFXXC4HS-25UI-DFXXC42026-05-06
00628101632434Ohio HS-30U2-CFDFC4 HS-30U2-CFDFC42026-05-05
00628101632441Ohio HS-30UW-CFDFC5 HS-30UW-CFDFC52026-05-05
00628101632533OhioHS-CS-RM-02002HS-CS-RM-020022026-05-05
00628101632489Ohio HS-25UC-DFF4C4 HS-25UC-DFF4C42026-04-17
00628101608187OhioFI-T01UO-DN-EFI-T01UO-DN-E2026-04-15
00628101608194OhioFI-T01UO-ON-EFI-T01UO-ON-E2026-04-15
00628101608200OhioFI-T03UO-CN-BFI-T03UO-CN-B2026-04-15
00628101608217OhioFI-T03UO-CN-EFI-T03UO-CN-E2026-04-15
00628101608224OhioFI-T03UO-DN-BFI-T03UO-DN-B2026-04-15

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