AccessGUDID - DEVICE: Venner™ PneuX P.Y.™ ETT MRI (08885009190776)

GUDID

Device Identifier (DI) Information

Brand Name: Venner™ PneuX P.Y.™ ETT MRI
Version or Model: 901180
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 901180
Company Name: VENNER MEDICAL (SINGAPORE) PTE. LTD.

Primary DI Number: 08885009190776
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 659177273 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	Yes

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

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Product Code	Product Code Name
BTR	Tube, Tracheal (W/Wo Connector)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 8 Millimeter

Device Record Status

Public Device Record Key: fcf6bcaf-5396-4662-bcfd-ddf0333a23e1
Public Version Date: March 06, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
28885009190770	10	18885009190773		In Commercial Distribution	10 boxes in a carton
18885009190773	10	08885009190776		In Commercial Distribution	10 pouches in abox