FDA.reportPublic FDA data

GENTEC®

Primary DI
06970966669037
Brand
GENTEC®
Company
GENTEC(SHANGHAI)CORPORATION
Model
Y-VAC-CPLR-OH
Device description
Twin Coupler, Ohmeda, Vacuum
Published
2024-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
06970966669037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970966669037069709666690376970966669037

GMDN Terms#

Term, Definition table
TermDefinition
Carbon dioxide low pressure hoseA length of reinforced colour-coded flexible tubing produced according to ISO5359 and intended to conduct compressed carbon dioxide (CO2) from a CO2 terminal unit or CO2 cylinder to a medical device that functions with CO2 (e.g., ventilator, insufflation system). 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

Regulatory Flags#

DUNS number
545287658
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970966665220GENTEC®34U-OXY2023-08-01
06970966665886GENTEC®O-W200-F70-GS2023-08-01
06970966665893GENTEC®O-W200-F70-BS2023-08-01
06970966665909GENTEC®O-G200-F70-DS2023-08-01
06970966665916GENTEC®O-W200-F70-DS2023-08-01
06970966663936GENTEC®O-W200-F70 Series2023-07-05
06970966663721GENTEC®34I-OXY Series2023-06-21
06970966663776GENTEC®35I-OXY Series2023-06-21
06970966663820GENTEC®34U-OXY Series2023-06-21
06970966663875GENTEC®35U-OXY Series2023-06-21
06970966663929GENTEC®FM197A -70L-HS Series2023-06-21
06970966669167GENTEC®FMD197A Series2024-11-16
06970966669068GENTEC®FM-PTO2024-08-05
06970966669044GENTEC®Y-VAC-CPLR-DH2024-07-26
06970966669051GENTEC®Y-OXY-CPLR-OH2024-07-26
06970966666753GENTEC®195M-950D2024-06-28
06970966666371GENTEC® GMX30E-AIR/O2-DS-P152024-03-25
06970966666357GENTEC®882VR-200-00-T2023-12-26
06970966666340GENTEC®882VR-200-DS-T-1.5L2023-12-20
06970966666111GENTEC®881VR-200-DS-T-2.5L/Sld2023-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607411919220Salter Labs® Oxygen TubingSALTER LABSBYX2026-06-09
00607411919237Salter Labs® Oxygen TubingSALTER LABSBYX2026-06-09
00607411919244Salter Labs® Oxygen TubingSALTER LABSBYX2026-06-09
00607411919251Salter Labs® Oxygen Tubing (MedTronic)SALTER LABSBYX2026-06-09
B929C4NI024FNNFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
B929N4AIK240FHTFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
B929N4OXW240FHTFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
00848530108328Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-03
00848530108953Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530108960Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530108977Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109011Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109028Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109035Repair PartSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109073Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
10197344011230HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-02-13
10197344011155HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-02-12
10197344042401HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-02-12
10885632467431HalyardOWENS & MINOR DISTRIBUTION, INC.BYX2026-01-29
10889483234402curaplex®SUNMED, LLCBYX2025-12-31
10889483225639AirLife™SUNMED, LLCBYX2025-12-18
10889483229279AirLife™SUNMED, LLCBYX2025-12-18
10197344162710MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-12-12
10197344162727MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-12-12
10197344011780HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344012237HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344012244HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344012572HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344042258HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344165315MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-09-26