FDA UDI
In Commercial Distribution
🇺🇸 United States
Venner™ PneuX P.Y.™ ETT MRI
DI: 08885009190776
·
Model: 901180
·
VENNER MEDICAL (SINGAPORE) PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Venner™ PneuX P.Y.™ ETT MRI
- Primary DI
- 08885009190776
- Version / Model
- 901180
- Catalog Number
- 901180
- Company Name
- VENNER MEDICAL (SINGAPORE) PTE. LTD.
- Labeler DUNS
- 659177273
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2023-03-06
- Public Version Status
- Update
- Public Device Record Key
- fcf6bcaf-5396-4662-bcfd-ddf0333a23e1
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- Yes
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | Anesthesiology | 868.5730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46569 | Reinforced endotracheal tube, single-use | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 28885009190770 | GS1 | 10 boxes in a carton | 10 | In Commercial Distribution | |
| Package | 18885009190773 | GS1 | 10 pouches in abox | 10 | In Commercial Distribution | |
| Primary | 08885009190776 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 8 | Millimeter |