Venner™ PneuX P.Y.™ TT MRI 902170
GUDID 28885009190824
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 ID | 28885009190824 |
| NIH Device Record Key | 60d850a4-d4ee-4a82-82c4-c985cb2b3add |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Venner™ PneuX P.Y.™ TT MRI |
| Version Model Number | 902170 |
| Catalog Number | 902170 |
| 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 | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08885009190820 [Primary] |
| GS1 | 18885009190827 [Package] Contains: 08885009190820 Package: 10 pouches in a box [10 Units] In Commercial Distribution |
| GS1 | 28885009190824 [Package] Contains: 18885009190827 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 |
Trademark Results [Venner]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VENNER 77621249 4305467 Live/Registered |
INDIAN OCEAN MEDICAL INC. 2008-11-25 |
 VENNER 77621241 not registered Dead/Abandoned |
Venner Capital S.A. 2008-11-25 |
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