FDA.reportPublic FDA data

Ohio

Primary DI
00628101600976
Brand
Ohio
Company
OHIO MEDICAL, LLC
Model
HS-CS-MA-02028
Catalog number
HS-CS-MA-02028
Device description
AGA N2O HOSE F/M 3.0M
Published
2026-02-18
Public version status
New
Distribution status
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
00628101600976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628101600976006281016009766281016009760628101600976

GMDN Terms#

Term, Definition table
TermDefinition
Nitrous oxide low pressure hoseA 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.

Sterilization Methods#

Method table
Method

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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628101633028OhioHS-50UW-DFDFC4HS-50UW-DFDFC42026-10-26
00628101633035OhioHS-50U2-DFDFC4HS-50U2-DFDFC42026-10-26
00628101633479OhioHS-07UA-CMM4C4HS-07UA-CMM4C42026-10-26
00628101633622OhioHS-13UA-OFOMC4HS-13UA-OFOMC42026-10-26
00628101633639OhioHS-13UO-OFOMC4HS-13UO-OFOMC42026-10-26
00628101633653OhioHS-20UV-F2OMN4HS-20UV-F2OMN42026-10-26
00628101633660OhioHS-20UW-F2F4N5HS-20UW-F2F4N52026-10-26
00628101624248OhioFM-LT-1515NOFM-LT-1515NO2026-10-22
00628101624385OhioFM-LT-0303NOFM-LT-0303NO2026-10-22
00628101624392OhioFM-T-0101NOFM-T-0101NO2026-10-22
00628101624408OhioFM-T-0303NOFM-T-0303NO2026-10-22
00628101624415OhioFM-T-1515NOFM-T-1515NO2026-10-22
00628101629236OhioFM-LT-1515UOFM-LT-1515UO2026-10-22
00628101629243OhioFM-OT-1515UOFM-OT-1515UO2026-10-22
00628101629250OhioFM-T-1515UOFM-T-1515UO2026-10-22
00628101629922OhioFM-T-1515NAFM-T-1515NA2026-10-22
00628101629939OhioFM-OT-1515NOFM-OT-1515NO2026-10-22
00628101630379OhioFM-OT-1515NAFM-OT-1515NA2026-10-22
00628101630386OhioFM-T-1515IOFM-T-1515IO2026-10-22
00628101630454OhioFM-T-1515UAFM-T-1515UA2026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628101633028OhioOHIO MEDICAL, LLCBYX2026-10-26
00628101633035OhioOHIO MEDICAL, LLCBYX2026-10-26
00628101633479OhioOHIO MEDICAL, LLCBYX2026-10-26
00628101633622OhioOHIO MEDICAL, LLCBYX2026-10-26
00628101633639OhioOHIO MEDICAL, LLCBYX2026-10-26
00628101633653OhioOHIO MEDICAL, LLCBYX2026-10-26
00628101633660OhioOHIO MEDICAL, LLCBYX2026-10-26
00628101633448OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633455OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633462OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633530OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633547OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633554OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633585OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633592OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633608OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633615OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633400OhioOHIO MEDICAL, LLCBYX2026-10-12
00749756403375DeRoyalDEROYAL INDUSTRIES, INC.BYX2026-09-30
00628101633356OhioOHIO MEDICAL, LLCBYX2026-09-29
00628101633417OhioOHIO MEDICAL, LLCBYX2026-09-29
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