HSA · registration DE0508229

Cook Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set

Name: Cook Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set — HSA DE0508229
Creator: Cook Incorporated
Keywords: Cook Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set, Cook Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set, DE0508229, General Hospital, HSA

SingaporeGeneral HospitalClass CCook Incorporated

Verified

Official record identity

Registration number: DE0508229
Model name: Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set; Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set
Model identifier: C-PTIS-100-HC-G-EU-FLEX7.5; C-PTIS-100-HC-G-EU-FLEX8.5
Registration date: June 22, 2023
Source update date: December 17, 2024

Classification

Risk class: Class C
Published category: General Hospital

Published parties

Product owner: Cook Incorporated
Registrant / registration holder: COOK SOUTH EAST ASIA PTE LTD

Official description

The Blue Rhino® G2-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g. ICU or operating room) with the assistance of trained personnel.

Additional source fields

Product owner address: 750 Daniels Way, Bloomington Indiana 47404, USA, United States
Registrant address: 38 BEACH ROAD, #29-11, SOUTH BEACH TOWER, Singapore 189767

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.