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

  • 05714188502106 ()


  • Haematological concentrate system preparation kit, platelet concentration
Used to attach and hold the 3C Patch Device with the supplied venipuncture set.
Reapplix ApS
2
In Commercial Distribution

  • 05714188501000 ()


  • Haematological concentrate system preparation kit, platelet concentration
No Description
VERICEL CORPORATION
366643
In Commercial Distribution

  • 00850037506156 ()


  • Evacuated blood collection tube IVD, anticoagulant
30ML Platelet Rich Plasma production device.
Bimini Technologies LLC
530102-1
In Commercial Distribution

  • 00850034511979 ()
  • 00850034511962 ()


  • Haematological concentrate system
15ML Platelet Rich Plasma production device.
Bimini Technologies LLC
530101-1
In Commercial Distribution

  • 00850034511955 ()
  • 00850034511948 ()


  • Haematological concentrate system
A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.
Bimini Technologies LLC
HEALPRP30
In Commercial Distribution

  • 00850034511832 ()


  • Haematological concentrate system
A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.
Bimini Technologies LLC
HEALPRP15
In Commercial Distribution

  • 00850034511429 ()
  • 00850034511597 ()


  • Haematological concentrate system
A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.
Bimini Technologies LLC
HEALPRP30
In Commercial Distribution

  • 00850034511443 ()
  • 00850034511580 ()


  • Haematological concentrate system
30mL Platelet Rich Plasma production device.
Bimini Technologies LLC
PROGEN-A30
In Commercial Distribution

  • 00850034511559 ()
  • 00850034511573 ()


  • Haematological concentrate system
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