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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

ECC PAck - 00607567204485

Gas Filter
DATASCOPE CORP.
BO-T 25101
Not in Commercial Distribution

  • 00607567204485 ()


  • Cardiopulmonary bypass system blood tubing set

10 Ft. 3/8 x 3/32 Tubing - 00607567204430

No Description
DATASCOPE CORP.
BO-T 20105
Not in Commercial Distribution

  • 00607567204430 ()
701048450

  • Cardiopulmonary bypass system blood tubing set

6ft 3/8x3/32 Tubing - 00607567204423

No Description
DATASCOPE CORP.
BO-T 20104
Not in Commercial Distribution

  • 00607567204423 ()
701048444

  • Cardiopulmonary bypass system blood tubing set

6ft 1/4x1/16 Tubing - 00607567204416

No Description
DATASCOPE CORP.
BO-T 20102
Not in Commercial Distribution

  • 00607567204416 ()
701048433

  • Cardiopulmonary bypass system blood tubing set

10ft 1/2x3/32 Tubing - 00607567204409

No Description
DATASCOPE CORP.
BO-T 20101
In Commercial Distribution

  • 00607567204409 ()
701048426

  • Cardiopulmonary bypass system blood tubing set

6ft 1/2x3/32 Tubing - 00607567204393

No Description
DATASCOPE CORP.
BO-T 20100
Not in Commercial Distribution

  • 00607567204393 ()
701048423

  • Cardiopulmonary bypass system blood tubing set

10ft 1/4x1/16 Tubing - 00607567204331

No Description
DATASCOPE CORP.
BO-T 20103
Not in Commercial Distribution

  • 00607567204331 ()
7010148440

  • Cardiopulmonary bypass system blood tubing set

Tubing Pack - 00607567203952

BO-RF32 Rotaflow
DATASCOPE CORP.
BO-T 6600
Not in Commercial Distribution

  • 00607567203952 ()
701052324

  • Cardiopulmonary bypass system centrifugal pump

Custom Pack - 00607567203327

Prebypass filter w/o Vent Porous Media 3/8x1/2, Gas Filter
DATASCOPE CORP.
BO-T 25102
Not in Commercial Distribution

  • 00607567203327 ()
701052463

  • Cardiopulmonary bypass system blood tubing set

Perfusion Pack 3/8" - 00607567202665

Softshell Venous Reser. 800ml, Gish Bladder Bag 30ml 1/4, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter
DATASCOPE CORP.
BO-T 13303
Not in Commercial Distribution

  • 00607567202665 ()
701052539

  • Cardiopulmonary bypass system blood tubing set

Hemobag Adapter - 00607567202092

No Description
DATASCOPE CORP.
BO-T 2917
Not in Commercial Distribution

  • 00607567202092 ()
701053384

  • Cardiopulmonary bypass system blood tubing set

Descending Thoracic Pack - 00607567201774

BO-RF32 RotaFlow
DATASCOPE CORP.
BO-T 22800
Not in Commercial Distribution

  • 00607567201774 ()
701051272

  • Cardiopulmonary bypass system blood tubing set

BUMC ECC Pack - 00607567211742

BO-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BO-T 41301
In Commercial Distribution

  • 00607567211742 ()
701065209R01

  • Cardiopulmonary bypass system blood tubing set

Pediatric Adapted Circuit - 00607567211650

BO-RF32 RotaFlow, BMU Cell Ven. 1/2, Arterial Sensor 3/8" (BMU), Prebypass filter w/o Vent Porous Media 3/8x1/2, Gas Filter
DATASCOPE CORP.
BO-T 26300
Not in Commercial Distribution

  • 00607567211650 ()
701066738R01

  • Cardiopulmonary bypass system blood tubing set

Small Adult Cardiac Surgery Pack - 00607567211551

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

  • 00607567211551 ()
709000004R01

  • Cardiopulmonary bypass system blood tubing set

¼” x ¼” Pediatric Pack - TEMPORARY - 00607567211544

No Description
DATASCOPE CORP.
BO-T 52303
In Commercial Distribution

  • 00607567211544 ()
709000408

  • Cardiopulmonary bypass system blood tubing set

Rotaflow Pack CD Softline - 00607567211490

Softshell Venous Reser. 1900ml w. connector 700000292, BO-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BO-T 39705
In Commercial Distribution

  • 00607567211490 ()
709000415

  • Cardiopulmonary bypass system blood tubing set

8ft 3/8X3/32 Tubing 68A - 00607567211476

No Description
DATASCOPE CORP.
BO-T 14608
Not in Commercial Distribution

  • 00607567211476 ()
709000224

  • Cardiopulmonary bypass system blood tubing set

2ft 3/8x3/32 Tubing 68A - 00607567211469

No Description
DATASCOPE CORP.
BO-T 14607
Not in Commercial Distribution

  • 00607567211469 ()
709000222

  • Cardiopulmonary bypass system blood tubing set

8ft 1/2/x3/32 tubing 68A - 00607567211452

No Description
DATASCOPE CORP.
BO-T 14606
Not in Commercial Distribution

  • 00607567211452 ()
709000220

  • Cardiopulmonary bypass system blood tubing set
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