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ICU Medical ChemoLock™ Needlefree Closed System Drug Transfer Device - HSA Registration DE0019021

Access comprehensive regulatory information for ICU Medical ChemoLock™ Needlefree Closed System Drug Transfer Device in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0019021 and owned by ICU Medical Inc.. The device was registered on March 02, 2017.

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
DE0019021
ICU Medical ChemoLock™ Needlefree Closed System Drug Transfer Device
HSA Registration Number: DE0019021
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Product Description

The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needle-free and cannot be deactivated, which will passively aid in preventing needle stick injuries and the exposure to cytotoxic medications for healthcare personnel.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0019021
Registration Date
March 02, 2017
Change Notification Approval Date
July 18, 2023
Retention Due Date
March 01, 2026
Product Owner
Short Name
ICU Medical Inc.
Address
951 Calle Amanecer San Clemente, CA 92673, UNITED STATES
Registrant
Address
65 UBI ROAD 1, OXLEY BIZHUB, #04-30, SINGAPORE 408729
Importer
Address
65 UBI ROAD 1, OXLEY BIZHUB, #04-30, SINGAPORE 408729
Model Information
Model Name(s)
ChemoLock™ Bag Spike ChemoLock™ Bag Spike with Additive Port, Dry Spike ChemoLock™ Bag Spike with Additive Port ChemoLock™ Vented Bag Spike Double ChemoLock™ Port Syringe Transfer Set ChemoLock™ Vented Vial Spike ChemoLock™ Universal Vented Vial Spike Locking Universal Vented Vial Spike, ChemoLock™ ChemoLock™ Closed Vial Spike ChemoLock™ Vial Spike, 20mm ChemoLock™ Vial Spike, 28mm ChemoLock™ Priming Device ChemoLock™ Injector ChemoLock™ ChemoLock™ Port 31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock™ Drip Chamber, Spiros®, Bag Hanger 17" (43 cm) Appx 5.4 ml, Bifuse Add-On Set w/ChemoLock™, 3 Clamps (Blue, 2 White), Dry Spike Adapter 14" Pentafuse Add-On Set w/4 ChemoLock™, 5 Clamps (Blue, 4 Red), Dry Spike Adapter 20" (51 cm) Appx 10.1 ml, Quadfuse Add-On Set w/3 ChemoLock™, 4 Clamps (Blue, 3 Red), Dry Spike Adapter 30" Admin Set w/2 ChemoLock™, 20 Drop In-Line Drip Chamber w/15 Micron Filter, Bag Hanger 18" (46 cm) Appx 7.8 ml, Trifuse Add-On Set w/2 ChemoLock™, 3 Clamps (Blue, 2 Red), Dry Spike Adapter 74" (188 cm) Appx 9.0 ml, 20 Drop Admin Set w/Integrated ChemoLock™ Port Drip Chamber, Rotating Luer, Bag Hanger Bag Spike w/ChemoLock™ Additive Port, Bulk Non-Sterile 15" (38 cm) Appx 4.5 ml, Bifuse Add-On Set w/ChemoLock™, Bag Spike, Check Valve, Vented Cap 43 cm (17") Appx 3.1 ml, Transfer Set w/ChemoLock™ Additive Port, Rotating Luer, Filter Cap 31'' (79 cm) Appx 3.7 ml, 20 Drop Admin Set w/15 Micron Filter, ChemoLock™ 30'' (76 cm) Appx 1.9 ml, PE/PVC 20 Drop Admin Set w/15 Micron Filter, ChemoLock™ 30" Admin Set w/2 ChemoLock™, 20 Drop In-Line Drip Chamber, Bag Hanger 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock™ Port Drip Chamber, ChemoLock™, Bag Hanger 40" (102 cm) Admin Set w/2 ChemoLock™, 20 Drop In-Line Drip Chamber, Bag Hanger 30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/Integrated ChemoLock™ Port Drip Chamber, 0.2 Micron Filter, ChemoLock™, Hanger 42" (107 cm) Appx 5.2 ml, Admin Set w/20 Drop In-Line Chamber, ChemoLock™, Bag Hanger 5" (13 cm) Appx 1.8 ml, Bag Spike Adapter w/ChemoLock™, Vented Cap 7" (18 cm) Appx 0.93 ml, Ext Set w/ChemoLock™, Y-Connector, Rotating Luer Bag Spike w/Clave™ Additive Port, ChemoLock™ Port ChemoLock™ Vial Spike, 13mm ChemoLock™ Vented Vial Spike, 20mm ChemoLock™ Vented Vial Spike, 13mm
Model Identifier(s)
011-CL-10 011-CL-12 011-CL-13 011-CL-14 011-CL-33 011-CL-51 011-CL-70 011-CL-74 011-CL-80 011-CL-80S 011-CL-80SL 011-CL-PRIME 011-CL2000 011-CL2000S 011-CL2100 011-CL3011 011-CL3187 011-CL3225 011-CL3226 011-CL3261 011-CL3266 011-CL3341 011-CL3342-NS 011-CL3343 011-CL3344 011-CL3345 011-CL3346 011-CL3446 011-CL3511 011-CL3520 011-CL3528 011-CL3529 011-CL3534 011-CL3535 011-CL4144 CL-62 CL-70S CL-72