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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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Softline Evanston Hospital Rotaflow Pack - 00607567208612

Softshell Venous Reser. 1900ml w. connector 700000292 BO-RF32 RotaFlow Gas Filter
DATASCOPE CORP.
BO-T 53500
In Commercial Distribution

  • 00607567208612 ()
709000226

  • Cardiopulmonary bypass system blood tubing set

3/16" x 1/4" Neonate Pack - 00607567208063

Stainless Steel Cooling coil BC 60 plus CDI Sat Cell 1/4" System 100 Gas Filter Temperature Probe
DATASCOPE CORP.
BO-T 46200
Not in Commercial Distribution

  • 00607567208063 ()
701065620

  • Cardiopulmonary bypass system blood tubing set

Small Adult Cardiac Surgery Pack - 00607567208056

Stainless Steel Cooling coil, BC 60 plus, CDI Sat Cell 3/8" System 100, Gas Filter, Temperature Probe
DATASCOPE CORP.
BO-T 2303
Not in Commercial Distribution

  • 00607567208056 ()
709000004

  • Cardiopulmonary bypass system blood tubing set

Pediatric Cardiac Surgery Pack - 00607567208049

Stainless Steel Cooling coil, BC 60 plus, CDI Sat Cell 3/8" System 100, Gas Filter and Temperature Probe.
DATASCOPE CORP.
BO-T 2302
Not in Commercial Distribution

  • 00607567208049 ()
709000006

  • Cardiopulmonary bypass system blood tubing set

BUMC Dallas ECC Priming Pack - 00607567208001

Blood Transfer Bag 600 ml
DATASCOPE CORP.
BO-T 41302
Not in Commercial Distribution

  • 00607567208001 ()
701066291

  • Cardiopulmonary bypass system blood tubing set

1/4" x 1/4" Pediatric Pack - 00607567207974

Stainless Steel Cooling coil BC 60 plus CDI Sat Cell 1/4" System 100 Gas Filter Temperature Probe
DATASCOPE CORP.
BO-T 46201
Not in Commercial Distribution

  • 00607567207974 ()
709000133

  • Cardiopulmonary bypass system blood tubing set

1/8 pigtail - 00607567207004

No Description
DATASCOPE CORP.
BO-T 31205
Not in Commercial Distribution

  • 00607567207004 ()
70900009

  • Cardiopulmonary bypass system blood tubing set

Table Line Pack - 00607567206953

No Description
DATASCOPE CORP.
BO-T 25106
Not in Commercial Distribution

  • 00607567206953 ()
701068046

  • Cardiopulmonary bypass system blood tubing set

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

Mayo Pulmonary Pk. Softline - 00607567204980

Softshell Venous Reser. 1900ml CDI Sat Cell 3/8" System 100 Gas Filter
DATASCOPE CORP.
BO-T 44201
Not in Commercial Distribution

  • 00607567204980 ()
701064834

  • Cardiopulmonary bypass system blood tubing set

Vent Line - 00607567204942

No Description
DATASCOPE CORP.
BO-T 30902
Not in Commercial Distribution

  • 00607567204942 ()
701062807

  • Cardiopulmonary bypass system blood tubing set
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