Truer Bougie Coiled

Primary DI
10859290006462
Brand
Truer Bougie Coiled
Company
TRUER MEDICAL, INC.
Model
90553
Device description
Truer Medical’s new Bougie is a latex-free, calibrated introducer designed to ensure accurate distance insertion.
Published
2023-09-22
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

Product Codes#

Code, Name table
CodeName
KCDBougie, Esophageal, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCDBougie, Esophageal, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859290006462PackageGS110In Commercial Distribution
00859290006465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085929000646210859290006462
00859290006465008592900064658592900064650859290006465

GMDN Terms#

Term, Definition table
TermDefinition
Endotracheal tube introducer, single-useA device designed to help with the insertion of an endotracheal (ET) tube into the airways of a patient during intubation. It is a long, thin, rod-like device, typically angled at the distal end, designed to improve directional control of the endotracheal tube during routine or difficult oral intubations. This is a single-use device.

Sterilization Methods#

Method table
Method

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183519285BR Surgical, LLCBR Surgical, LLCKCD2024-06-10
00859290006465Truer Bougie CoiledTRUER MEDICAL, INC.KCD2023-09-22
00859290006236Truer BougieTRUER MEDICAL, INC.KCD2022-08-29
00859290006229Adroit SurgicalTRUER MEDICAL, INC.KCD2018-01-23
00859290006212Adroit surgicalTRUER MEDICAL, INC.KCD2018-01-23
20859290006223Adroit SurgicalTRUER MEDICAL, INC.KCD2018-01-23