Ultra 8 Intra-aortic Balloon – Lightwave Sensor: Medical device shortage
The Ultra 8 Intra-aortic Balloon – Lightwave Sensor is currently reported as a medical device shortage under sections 62.21 to 62.26 of the Medical Devices Regulations. For a full list of shortages, refer to the List of shortages and discontinuations.
Posted on 2023-09-20Footnote 1
Type of report
Actual medical device shortage
Name of medical device (including any component, accessory or part that is in shortage, including the model name) if applicable
Ultra 8 Intra-aortic Balloon – Lightwave Sensor
Other names (for example trade name), if applicable
N/A
Package description (for example, packaging formats, sizes, quantities)
Catheter with component kit, quantity 1
Class of medical device (I, II, III or IV), if known
Class IV
Device identifier(s) (for example, serial number, catalogue number, part number, model number or unique device identifier)
IAB-05840-U
IAB-05830-U
IAB-05830-LWS
IAB-05840-LWS
Medical device licence number (for Class II, III and IV), if applicable
31021
Authorization identification number (for devices authorized for importation or sale under an interim order made under section 30.1 of the Food and Drugs Act), if applicable
N/A
Single-use product
Yes
Importers that have reported the shortage (Names of importers listed who have reported the shortage separately from the manufacturer or who are reporting on behalf of the manufacturer in a delegated capacity), if applicable
N/A
Manufacturer's name
Arrow International LLC Subsidiary Of Teleflex Inc
Manufacturer's mailing address
3015 Carrington Mill Blvd
Morrisville
North Carolina
USA 27560
Reason for shortage
Disruption of the manufacturing of a medical device.
Footnotes
- Footnote 1
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This date reflects when a shortage report is first posted online. This page includes specific information related to the device that is in shortage. Updates to the status and end date of a shortage can be found on the List of shortages webpage.
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