Venner™ PneuX P.Y.™ TT MRI 902190

GUDID 28885009190848

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).

VENNER MEDICAL (SINGAPORE) PTE. LTD.

Basic tracheostomy tube, single-use
Primary Device ID28885009190848
NIH Device Record Key18c4bcd2-8a79-403a-a7f4-2bd21ab35b55
Commercial Distribution StatusIn Commercial Distribution
Brand NameVenner™ PneuX P.Y.™ TT MRI
Version Model Number902190
Catalog Number902190
Company DUNS659177273
Company NameVENNER MEDICAL (SINGAPORE) PTE. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Producttrue
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter
Lumen/Inner Diameter9 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS108885009190844 [Primary]
GS118885009190841 [Package]
Contains: 08885009190844
Package: 10 pouches in a box [10 Units]
In Commercial Distribution
GS128885009190848 [Package]
Contains: 18885009190841
Package: 10 boxes in a carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTOTube, Tracheostomy (W/Wo Connector)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-05-06
Device Publish Date2016-09-24

On-Brand Devices [Venner™ PneuX P.Y.™ TT MRI]

28885009190848The Venner™ PneuX P.Y.™ Tracheostomy tube is designed to be used for patients undergoing Tra
28885009190831The Venner™ PneuX P.Y.™ Tracheostomy tube is designed to be used for patients undergoing Tra
28885009190824The Venner™ PneuX P.Y.™ Tracheostomy tube is designed to be used for patients undergoing Tra

Trademark Results [Venner]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VENNER
VENNER
77621249 4305467 Live/Registered
INDIAN OCEAN MEDICAL INC.
2008-11-25
VENNER
VENNER
77621241 not registered Dead/Abandoned
Venner Capital S.A.
2008-11-25

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