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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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Rotaflow - 00607567206793

BO-RF32 RotaFlow
DATASCOPE CORP.
BO-T 39102
Not in Commercial Distribution

  • 00607567206793 ()
701064307

  • Cardiopulmonary bypass system blood tubing set

3/8 Handup Pack - 00607567206557

No Description
DATASCOPE CORP.
BO-T 20208
Not in Commercial Distribution

  • 00607567206557 ()
701067396

  • Cardiopulmonary bypass system blood tubing set

1/4 Handup Pack - 00607567206540

No Description
DATASCOPE CORP.
BO-T 20207
Not in Commercial Distribution

  • 00607567206540 ()
701067394

  • Cardiopulmonary bypass system blood tubing set

ECC Ancilliary pack - 00607567206236

No Description
DATASCOPE CORP.
BO-T 4115
Not in Commercial Distribution

  • 00607567206236 ()
701067206

  • Cardiopulmonary bypass system blood tubing set

Tubing Pack 1/4" w/o Oxygenator - 00607567206014

Better Bladder 1/4, Blood Microfilter System SQ 40 S, Gas Filter
DATASCOPE CORP.
BO-T 4100
Not in Commercial Distribution

  • 00607567206014 ()
701066836

  • Cardiopulmonary bypass system blood tubing set

Cardioplegia Accessory Pack - 00607567205802

No Description
DATASCOPE CORP.
BO-T 30301
Not in Commercial Distribution

  • 00607567205802 ()
701066188

  • Cardioplegia solution administration kit

Isolated Prime Circuit - 00607567205529

No Description
DATASCOPE CORP.
BO-T 36503
Not in Commercial Distribution

  • 00607567205529 ()
701065590

  • Cardiopulmonary bypass system blood tubing set

BUMC ECC PAck - 00607567205253

BO-RF 32
DATASCOPE CORP.
BO-T 41301
Not in Commercial Distribution

  • 00607567205253 ()
701065209

  • Cardiopulmonary bypass system blood tubing set

Cardioplegia Dual Line Pack - 00607567205079

No Description
DATASCOPE CORP.
BO-T 36501
Not in Commercial Distribution

  • 00607567205079 ()
701064513

  • Cardioplegia solution administration kit

ECC 1/4 - 00607567205000

Softshell Venous Reser. 1900ml w. connector 700000292, BO-RF32 RotaFlow, CDI Sat Cell 1/4" System 100,
DATASCOPE CORP.
BO-T 21306
Not in Commercial Distribution

  • 00607567205000 ()
701064000

  • Cardiopulmonary bypass system blood tubing set
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