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B. Braun Introcan Safety® 2 Closed IV Catheter - HSA Registration DE0509315

Access comprehensive regulatory information for B. Braun Introcan Safety® 2 Closed IV Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509315 and owned by B. Braun Melsungen AG. The device was registered on May 25, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0509315
B. Braun Introcan Safety® 2 Closed IV Catheter
HSA Registration Number: DE0509315
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Product Description

The Introcan Safety® 2 Closed IV Catheter is inserted into a patient´s vascular system for short-term use to - sample venous or arterial blood, - monitor blood pressure, or - administer infusion solutions, blood products or pharmaceuticals (e.g. in or without carrier solutions) according to the SPC of the drug/ solution. • The Introcan Safety® 2 Closed IV Catheter is also indicated for subcutaneous infusion therapies according to the SPC of the drug/ solution. • The 18- 24 gauge catheters may be used with power injectors set at a maximum pressure of 325 psi and a recommended maximum flow rate. Use Luer lock connection only.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0509315
Registration Date
May 25, 2024
Change Notification Approval Date
April 11, 2025
Retention Due Date
May 24, 2025
Product Owner
Short Name
B. Braun Melsungen AG
Address
Carl-Braun-Str. 1, 34212 Melsungen, GERMANY
Registrant
Address
600 NORTH BRIDGE ROAD, PARKVIEW SQUARE, #15-05, SINGAPORE 188778
Importer
Address
600 NORTH BRIDGE ROAD, PARKVIEW SQUARE, #15-05, SINGAPORE 188778
Model Information
Model Name(s)
Introcan Safety® 2 Introcan Safety® 2 Introcan Safety® 2 Introcan Safety® 2 Introcan Safety® 2 Introcan Safety® 2 Introcan Safety® 2 Introcan Safety® 2 Introcan Safety® 2 Introcan Safety® 2 Introcan Safety® 2 Introcan Safety® 2 Introcan Safety® 2 Introcan Safety® 2 Introcan Safety® 2 Introcan Safety® 2
Model Identifier(s)
4242000-01 4242001-01 4242002-01 4242003-01 4242004-01 4242005-01 4242006-01 4242007-01 4242008-01 4242009-01 4242010-01 4242011-01 4242012-01 4242013-01 4242014-01 4242015-01