FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770529285
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
N8182 A
Catalog number
N8182 A
Device description
LARYNGECTOMY TUBE NYLON SIZE-8
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KACTube, Laryngectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KACTube, LaryngectomyEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770529285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770529285007577705292857577705292850757770529285

GMDN Terms#

Term, Definition table
TermDefinition
Laryngectomy tube, non-sterileA non-sterile hollow device intended to maintain tracheostoma patency after laryngectomy to provide an airway for the patient and to prevent tracheostomal stenosis in the months following the procedure. It is a soft plastic or silicone curved tube, similar to a tracheostomy tube, contoured to fit the postoperative tracheal anatomy, and may have an inner cannula and be fenestrated to allow simultaneous use with a tracheoesophageal speech valve. It is held in place with a strap or band around the neck and is typically regularly removed and reinserted by the patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
196603781
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00757770451531Bausch + LombSP7-54651E07132026-06-22
00757770668540Bausch + LombSP7-72946E41062026-06-22
00757770669431Bausch + LombSP7-66619X03002026-06-22
00757770676521Bausch + LombSP7-69197N1685 S152026-06-22
00757770419135Bausch + LombSP7-100344SP7-1003442026-05-11
00757770434268Bausch + LombSP7-100346SP7-1003462026-05-11
00757770652983Bausch + LombSP7-65819SP7-658192026-05-11
00757770683543Bausch + LombSP7-60918SP7-609182026-05-11
00757770683567Bausch + LombSP7-35672SP7-356722026-05-11
00757770688548Bausch + LombSP7-74835SP7-748352026-05-11
00757770714643Bausch + LombSP7-04989SP7-049892026-05-11
00757770714759Bausch + LombSP7-58985SP7-589852026-05-11
10757770529206Bausch + LombBL3124BL31242026-04-30
20757770455878Bausch + LombE3671E36712026-04-30
20757770457445Bausch + LombMVS 1022MVS 10222026-04-30
20757770457568Bausch + LombN0522 DN0522 D2026-04-30
20757770457650Bausch + LombN2398 3N2398 32026-04-30
20757770457667Bausch + LombN2398 4N2398 42026-04-30
20757770457674Bausch + LombN2398 5N2398 52026-04-30
20757770457759Bausch + LombN4847N48472026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904428723706OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723713OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723720OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723737OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723744OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723751OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723768OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723775OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723782OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723799OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723805OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428723812OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312010OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312027OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312034OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312041OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312058OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312065OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312072OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039312089OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747900OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747917OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747924OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747931OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747948OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747955OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747962OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747979OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747986OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747993OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12