FDA.reportPublic FDA data

Gas Sampling Line 120'x.048'x.108' M/F

Primary DI
20859290006278
Brand
Gas Sampling Line 120'x.048'x.108' M/F
Company
TRUER MEDICAL, INC.
Model
90101
Catalog number
90101
Device description
Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
Published
2022-06-30
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
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
10859290006271PackageGS150In Commercial Distribution
20859290006278PackageGS18In Commercial Distribution
00859290006274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085929000627110859290006271
2085929000627820859290006278
00859290006274008592900062748592900062740859290006274

GMDN Terms#

Term, Definition table
TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible tube(s) primarily intended to be used as an interface between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor]. It may be intended for pressure and flow monitoring and/or gas sampling, but does not include any components intended for delivery of medical gas to the patient; a microbial filter may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7146289785ttruitt@truermedical.com

Regulatory Flags#

DUNS number
003530786
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859290006489Sharn by MarketlabSharn SSP-4002024-10-29
10859290006486Sharn by MarketlabSharn SSP-4002024-10-29
00859290006472HP to 3.5mm Phonojack Cable with Shrinkwrap70309703092024-01-16
00859290006465Truer Bougie Coiled905532023-09-22
10859290006462Truer Bougie Coiled905532023-09-22
00859290006441400 Series Right Angle Cable (80 cm)703232023-07-19
00859290006458400 Series Right Angle Cable (160 cm)703262023-07-19
00859290006359Pediatric Stylet90201902012022-06-30
00859290006342Adult Stylet90200902002022-06-30
00859290006434CO EX LINE 96'X.048'X112' M/M90116901162022-12-09
00859290006410Nasal Cannula 90413904132022-09-08
10859290006417Nasal Cannula 90413904132022-09-08
00859290006236Truer Bougie905522022-08-29
00859290006274Gas Sampling Line 120'x.048'x.108' M/F90101901012022-06-30
00859290006281Gas Sampling Line 120'x.040'x.112' M/M 90148901482022-06-30
00859290006298Gas Sampling Line 120'X.050'x.108' M/M90150901502022-06-30
00859290006304GAS SAMPLING LINE 120'x.050'x.108' M/F90151901512022-06-30
00859290006311GAS SAMPLING LINE 96'x.050'x.112' MM90156901562022-06-30
00859290006328GAS SAMPLING LINE 120' X .050' X .112' M/M90158901582022-06-30
00859290006267Gas Sampling Line 120 x .048 x .108 M/M CO-EX90100901002022-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756403375DeRoyalDEROYAL INDUSTRIES, INC.BYX2026-09-30
00628101633356OhioOHIO MEDICAL, LLCBYX2026-09-29
00628101633417OhioOHIO MEDICAL, LLCBYX2026-09-29
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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
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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