Venner™ PneuX P.Y.™ TT MRI 902180

GUDID 28885009190831

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 Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use

• Primary Device ID: 28885009190831
• NIH Device Record Key: 2e4e36cc-114c-488e-a69a-edd1704cb210
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venner™ PneuX P.Y.™ TT MRI
• Version Model Number: 902180
• Catalog Number: 902180
• Company DUNS: 659177273
• Company Name: VENNER MEDICAL (SINGAPORE) PTE. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter
• Lumen/Inner Diameter: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08885009190837 [Primary]
GS1	18885009190834 [Package]; Contains: 08885009190837; Package: 10 pouches in a box [10 Units]; In Commercial Distribution
GS1	28885009190831 [Package]; Contains: 18885009190834; Package: 10 boxes in a carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100950

FDA Product Code

• BTO: Tube, Tracheostomy (W/Wo Connector)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-06
• Device Publish Date: 2016-09-24

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

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