Medical device – airway management / patient connection
Flexible double swivel catheter mount, 22F - flip top cap with 7.6mm port - 22M/15F, \u2265170mm
Certifications
Covered by Intersurgical Ltd EC Declaration of Conformity for catheter mounts, confirming compliance with European Medical Devices Directive 93/42/EEC (and transposing legislation) for class IIa medical devices.
Assessed under Annex II (Full Quality Assurance System, excluding section 4) of Directive 93/42/EEC under the supervision of Notified Body 1639, SGS Belgium NV.
EC Certificate Full Quality Assurance System GB19/964232 issued for the management system of Intersurgical Ltd as referenced in the Declaration of Conformity.
Covered by Intersurgical Ltd EC Declaration of Conformity for catheter mounts, confirming compliance with European Medical Devices Directive 93/42/EEC (and transposing legislation) for class IIa medical devices.
Assessed under Annex II (Full Quality Assurance System, excluding section 4) of Directive 93/42/EEC under the supervision of Notified Body 1639, SGS Belgium NV.
EC Certificate Full Quality Assurance System GB19/964232 issued for the management system of Intersurgical Ltd as referenced in the Declaration of Conformity.
Class IIa medical device classification (rule 2, Annex IX, Medical Devices Directive 93/42/EEC) with GMDN codes 42476 and 46819 for catheter mounts.
Description
Flexible Catheter Mount 22F Swivel Elbow 22M/15F (Intersurgical code 3516000) is a flexible double swivel catheter mount with a 22F female connector at one end and a 22M/15F connector at the other, with an integral flip top cap incorporating a 7.6 mm port and an overall length of approximately 170 mm. It is part of Intersurgical’s flexible catheter mounts range within their airway management patient connections portfolio and is intended for use as a breathing system patient connection in applications such as anaesthesia, critical care, resuscitation and patient transfer, providing a flexible link between the breathing system and the patient airway device.
Bnefits
Flexible double swivel design between 22F and 22M/15F connectors to facilitate patient positioning and reduce mechanical strain on the airway device and breathing system.
Flip top cap with 7.6 mm port allowing insertion of standard 7.6 mm probes or suction catheters through the port while maintaining a closed connection when not in use.
Part of a range of catheter mounts providing a variety of elbow connections and ports for different clinical applications.
Port caps are tethered (fixed) to the connectors to help prevent loss or misplacement during use.
Known compressible volume of approximately 47 ml and length of about 170 mm for predictable performance characteristics within breathing circuits.
Available in both standard version (3516000) and sterile version (3516000S) to suit different clinical and procurement requirements.
Indications
Use as a flexible catheter mount / patient connection component in breathing systems for airway management in anaesthesia, critical care and resuscitation.
Use in clinical applications where a flexible connection is required between the patient’s airway device and the breathing circuit, including theatre, recovery and patient transfer.
Use in situations where access for suctioning or insertion of standard 7.6 mm probes via a flip top port is required while maintaining a secure breathing system connection.
Class IIa medical device classification (rule 2, Annex IX, Medical Devices Directive 93/42/EEC) with GMDN codes 42476 and 46819 for catheter mounts.
Manufacturer certified to ISO 14001:2015, ISO 9001:2015, ISO 13485:2016 and MDSAP, as stated in the Intersurgical catheter mount range information sheet.
CE marked medical device placed on the market in accordance with the applicable European medical device legislation at the time of the Declaration of Conformity.
Manufacturer certified to ISO 14001:2015, ISO 9001:2015, ISO 13485:2016 and MDSAP, as stated in the Intersurgical catheter mount range information sheet.
CE marked medical device placed on the market in accordance with the applicable European medical device legislation at the time of the Declaration of Conformity.
Flexible double swivel catheter mount, 22F - flip top cap with 7.6mm port - 22M/15F, \u2265170mm
Not publicly listed
Formulation
Flexible catheter mount with double swivel design between connectors.
Connector configuration: 22F female connector at one end; 22M/15F connector at the other end.
Integral flip top cap with 7.6 mm port for compatibility with standard 7.6 mm probes and suction catheters.
Approximate length: 170 mm.
Approximate compressible volume: 47 ml.
Standard product code 3516000 supplied in boxes of 50 units; sterile version 3516000S supplied in boxes of 85 units.
Class IIa medical device under the European Medical Devices Directive 93/42/EEC.
Packaging
Intersurgical manufacturer packaging: code 3516000 supplied in boxes of 50 catheter mounts.
Sterile variant 3516000S supplied in boxes of 85 catheter mounts according to manufacturer information sheet.
Retailers such as Medisave and other medical suppliers also offer the product as individual units for purchase.
Pack labelling and instructions for use are provided by Intersurgical and referenced in the manufacturer’s documentation and Declaration of Conformity.
Usage
Use only by appropriately trained healthcare professionals in accordance with local clinical protocols and the manufacturer’s instructions for use supplied with the device.
Connect the 22F end to the appropriate breathing system component and the 22M/15F end to the compatible patient airway device or interface, ensuring all connections are secure before use.
The flip top cap with 7.6 mm port may be opened as required to allow insertion of standard 7.6 mm probes or suction catheters through the port, then closed again when not in use.
The manufacturer’s product pages and information sheets instruct users to follow the instructions for use (IFU) provided with the product; detailed step-by-step IFU text is not published in full on public web pages.
