Portex

Portex - 100/199/085

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).

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 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