FDA.reportPublic FDA data

Venner™ PneuX P.Y.™ TT

Primary DI
08885009190806
Brand
Venner™ PneuX P.Y.™ TT
Company
VENNER MEDICAL (SINGAPORE) PTE. LTD.
Model
902080
Catalog number
902080
Device description
The Venner™ PneuX P.Y.™ Tracheostomy tube is designed to be used for patients undergoing Tracheal intubation during extended periods (not more than 30 days) of intensive or critical care, and for evacuation or drainage of secretion from the subglottic space.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTOTube, Tracheostomy (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTOTube, Tracheostomy (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100950000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100950000VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBEVenner Medical (Singapore) Pte, Ltd.2010-07-13BTO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18885009190803PackageGS110In Commercial Distribution
28885009190800PackageGS110In Commercial Distribution
08885009190806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1888500919080318885009190803
2888500919080028885009190800
08885009190806088850091908068885009190806

GMDN Terms#

Term, Definition table
TermDefinition
Basic tracheostomy tube, single-useA sterile hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes to meet the individual needs of the patient. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter8Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
659177273
Device count
1
HCT/P
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08885009190752Venner™ PneuX P.Y.™ ETT MRI9011609011602016-09-24
08885009190769Venner™ PneuX P.Y.™ ETT MRI9011709011702016-09-24
08885009190776Venner™ PneuX P.Y.™ ETT MRI9011809011802016-09-24
08885009190783Venner™ PneuX P.Y.™ ETT MRI9011909011902016-09-24
08885009190820Venner™ PneuX P.Y.™ TT MRI9021709021702016-09-24
08885009190837Venner™ PneuX P.Y.™ TT MRI9021809021802016-09-24
08885009190844Venner™ PneuX P.Y.™ TT MRI9021909021902016-09-24
08885009190707Venner™ Tracheal Seal Monitor9032009032002016-09-24
08885009190714Venner™ PneuX P.Y.™ ETT 9010609010602016-09-24
08885009190721Venner™ PneuX P.Y.™ ETT9010709010702016-09-24
08885009190738Venner™ PneuX P.Y.™ ETT9010809010802016-09-24
08885009190745Venner™ PneuX P.Y.™ ETT9010909010902016-09-24
08885009190790Venner™ PneuX P.Y.™ TT9020709020702016-09-24
08885009190813Venner™ PneuX P.Y.™ TT9020909020902016-09-24
08885009190196APA™ Stylet 7010097010092019-02-25
08885009190851Venner™ Tracheal Seal Monitor Extension Tube9030019030012016-09-24
28885009190855Venner™ Tracheal Seal Monitor Extension Tube9030019030012016-09-24
08885009190325APA™ O2 MAC 3 Blade7003307003302019-08-22
08885009190332APA™ O2 MAC 4 Blade7003407003402019-08-22
08885009190349APA™ O2 DAB7003707003702019-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783010640Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010657Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010664Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010671Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010695Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010701Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010718Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010725Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010732Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010749Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010756Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010770Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010787Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010794Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010800Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010817Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010824Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010831Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010848Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010855Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010862Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010879Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010886Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010893Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010909Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010916Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010923Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010930Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010947Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010954Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09