FDA.reportPublic FDA data

Venner™ PneuX P.Y.™ ETT MRI

Primary DI
08885009190783
Brand
Venner™ PneuX P.Y.™ ETT MRI
Company
VENNER MEDICAL (SINGAPORE) PTE. LTD.
Model
901190
Catalog number
901190
Device description
The Venner™ PneuX P.Y.™ Endotracheal 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) and compatible with Tracheal intubation during routine anaesthesia.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTRTube, Tracheal (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18885009190780PackageGS110In Commercial Distribution
28885009190787PackageGS110In Commercial Distribution
08885009190783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1888500919078018885009190780
2888500919078728885009190787
08885009190783088850091907838885009190783

GMDN Terms#

Term, Definition table
TermDefinition
Reinforced endotracheal tube, single-useAn armoured hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. It is wire reinforced to prevent kinking during patient movement and may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) have a built-in pilot balloon. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter9Millimeter

Regulatory Flags#

DUNS number
659177273
Device count
1
HCT/P
true
Lot or batch
true
Serial number
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
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
08885009190349APA™ O2 DAB7003707003702019-08-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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