FDA.reportPublic FDA data

CO EX LINE 96'X.048'X112' M/M

Primary DI
00859290006434
Brand
CO EX LINE 96'X.048'X112' M/M
Company
TRUER MEDICAL, INC.
Model
90116
Catalog number
90116
Device description
Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials
Published
2022-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10859290006431PackageGS1500In Commercial Distribution
00859290006434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085929000643110859290006431
00859290006434008592900064348592900064340859290006434

GMDN Terms#

Term, Definition table
TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible noninvasive tube(s) primarily intended to be connected 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] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
7146289785ttruitt@truermedical.com

Regulatory Flags#

DUNS number
003530786
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
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
00859290006335GAS SAMPLING LINE 120'X.060'X.112' M/M90169901692022-06-30

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