Portex - 100/199/085
Device Description
A small chamber, usually wall-mounted, used for the emergency resuscitation of newborn infants who do not breathe spontaneously at birth and are oxygen deficient. It typically has a front door or lid that folds out to serve as a surface upon which the infant is placed. It is typically equipped with a heating lamp, a low-pressure suction system, an oxygen (O2) supply, a gas mixer (oxygen/air), and a resuscitator. It may be supplied with the resuscitation devices or empty, in which case the resuscitation devices are fitted by another party (e.g., hospital clinical engineer, device supplier).
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: BTR
Device Name: Tube, Tracheal (W/Wo Connector)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: Y
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.5730
Third Party Flag: N
Medical Specialty: AN
Device IdentifiersDevice Id: 35019315022351
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15019315022357
Package Quantity: 20
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 15019315022357
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 55019315022355
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 35019315022351
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The information provided on this site includes data supplied by The GMDN Agency ("GMDN Content"), which is used under licence from The GMDN Agency. Any data/information suppliers who wish to extract GMDN Content from this site in order to use it as a basis for creating and supporting commercial services such as alternative categorisation, alternative GMDN Term assignment, mapping to other categorisations or ontologies, or for AI training purposes, must first obtain an appropriate licence from The GMDN Agency. No such activity is permitted without a licence. For more information on obtaining a licence, please contact The GMDN Agency (https://www.gmdnagency.org/contact-us/). None of the GMDN content constitutes any endorsement, advice, representation or warranty about any specific medical devices that may be described by such content; and no representation or warranty is made in relation to instructions for use, suitability for any application, treatment or condition, regulatory status, or any properties of a particular medical device.
GMDN ®. © GMDN Agency 2005-.