FDA.reportPublic FDA data

Venner™ PneuX P.Y.™ TT MRI

Primary DI
28885009190831
Brand
Venner™ PneuX P.Y.™ TT MRI
Company
VENNER MEDICAL (SINGAPORE) PTE. LTD.
Model
902180
Catalog number
902180
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. It is also safety in an MRI environment (indicated MRI).
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
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
18885009190834PackageGS110In Commercial Distribution
28885009190831PackageGS110In Commercial Distribution
08885009190837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1888500919083418885009190834
2888500919083128885009190831
08885009190837088850091908378885009190837

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
DM exempt
false
Premarket exempt
false
HCT/P
true
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
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
08885009190806Venner™ PneuX P.Y.™ TT9020809020802016-09-24
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

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