FDA.reportPublic FDA data

Ohio

Primary DI
00628101633417
Brand
Ohio
Company
OHIO MEDICAL, LLC
Model
HS-13IO-DCDEC4
Catalog number
HS-13IO-DCDEC4
Device description
13' HOSE ASMBLY ISO OXY DC*DE COND 1/4"
Published
2026-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00628101633417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628101633417006281016334176281016334170628101633417

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; some types may include an integrated mount. 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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628101633356OhioHS-01UC-DADCN4HS-01UC-DADCN42026-09-29
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
00628101632502OhioHS-13U2-DFXXC4HS-13U2-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756403375DeRoyalDEROYAL INDUSTRIES, INC.BYX2026-09-30
00628101633356OhioOHIO 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
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