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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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4 x (21G Needle + 3C Patch® Needle Holder) - 05714188505206

This is the retail bag label for the retail bag, which contains 6 venipuncture needle sets (commercially available) and 6 3C Patch Needle Holders.
Reapplix ApS
2
In Commercial Distribution

  • 05714188505206 ()


  • Haematological concentrate system preparation kit, platelet concentration

3C Patch® Kit - 05714188505008

Kit that includes 3C Patch Device, 3C Patch Needle Holder, Venipuncture Needle Set (commercially available), Skin Preparation Alcohol Swab (commercially available), Post-Sampling Adhesive Bandage (band aid) (commercially available), and Primary Wound Cover Dressing (commercially available).
Reapplix ApS
2
In Commercial Distribution

  • 05714188505008 ()


  • Haematological concentrate system preparation kit, platelet concentration

3C Patch® Device - 05714188502106

Holds the blood at collection and during processing in the centrifuge.
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2
In Commercial Distribution

  • 05714188502106 ()


  • Haematological concentrate system preparation kit, platelet concentration

3C Patch® Needle Holder - 05714188501000

Used to attach and hold the 3C Patch Device with the supplied venipuncture set.
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2
In Commercial Distribution

  • 05714188501000 ()


  • Haematological concentrate system preparation kit, platelet concentration

3C Patch® Device - Extra Component Set - 05714188505602

This is the outer label for the box that contains 20 3C Patch Deviceds and the IFU.
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2
Not in Commercial Distribution

  • 05714188505602 ()


  • Haematological concentrate system preparation kit, platelet concentration

Box - 3C Patch® Kit - 05714188505503

This is the outer label for the box that includes 12 3C Patch® Kits and the IFU.
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2
In Commercial Distribution

  • 05714188505503 ()


  • Haematological concentrate system preparation kit, platelet concentration

3CP™ Centrifuge Kit - 05714188308005

Kit that includes 3CP Centrifuge, power cord, external power supply, 3CP Counterbalance, bag with centrifuge tools, display protection shield, and 3CP Manual.
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2
In Commercial Distribution

  • 05714188308005 ()


  • Haematological concentrate system centrifuge

3CP™ Counterbalance - 05714188301808

Used with 3CP Centrifuge to counterbalance weight of 3C Patch Device(s).
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2
In Commercial Distribution

  • 05714188301808 ()


  • Centrifuge tube counterbalance

BrainCheck Assess - 00860011154501

BrainCheck Assess is a digital cognitive assessment platform.
Braincheck, Inc.
2
In Commercial Distribution

  • 00860011154501 ()


  • Cognitive assessment software

Zemits Leger - 00860010841105

Large-area electric massager
Advance-Esthetic LLC
2
In Commercial Distribution

  • 00860010841105 ()
2003181

  • Freestanding electric massager
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