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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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LINE, ARTERIAL FILTER PURGE - B0662010080000

A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device.
NOVOSCI CORP.
201008-000
In Commercial Distribution

  • B0662010080000 ()
  • B0662010080007 ()
  • B0662010080006 ()
  • B0662010080005 ()
  • B0662010080003 ()
201008-000

  • Cardiopulmonary bypass system filter, arterial blood line

CANNULAE, SAPHENOUS VEIN - B0662010060000

A sterile, single lumen, tubular device designed to deliver cardioplegic solution to the aortic root to stop the beating of the heart and maintain it dormant; it may also be used to vent the aorta and the left heart during a cardiopulmonary bypass procedure. It is typically made of plastic [e.g., polypropylene, polyvinyl chloride (PVC)] with a soft insertion tip and a suture flange for its anchoring; it may have one or more tubes (a second for aspiration, if needed), and typically Luer connector(s) for connection to the infusion syringe and aspiration line(s). It may include a manual tubing clamp and insertion is typically achieved with a removable stylet. This is a single-use device.
NOVOSCI CORP.
201006-000
In Commercial Distribution

  • B0662010060006 ()
  • B0662010060000 ()
  • B0662010060005 ()
  • B0662010060004 ()
  • B0662010060003 ()
201006-000

  • Cardioplegia cannula

NEEDLE, AIR ASPIRATOR 16 GA W/BLUE CAP - B0662010050000

A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. This is a single-use device.
NOVOSCI CORP.
201005-000
In Commercial Distribution

  • B0662010050006 ()
  • B0662010050000 ()
  • B0662010050005 ()
  • B0662010050004 ()
  • B0662010050003 ()
201005-000

  • Body aspiration needle, single-use

CRYOLOCK(Y) - B056CLRCTY1

Cryolock - Yellow Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
CL-R-CT(Y)
In Commercial Distribution

  • B056CLRCTY5 ()
  • B056CLRCTY2 ()
  • B056CLRCTY1 ()
  • B056CLRCTY0 ()
  • B056CLRCTY3 ()
  • B056CLRCTY7 ()
CL-R-CT (Yellow)

  • Assisted reproduction vitrification carrier

CRYOLOCK(O) - B056CLRCTO1

Cryolock - Orange Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
CL-R-CT(O)
In Commercial Distribution

  • B056CLRCTO5 ()
  • B056CLRCTO2 ()
  • B056CLRCTO1 ()
  • B056CLRCTO0 ()
  • B056CLRCTO3 ()
  • B056CLRCTO7 ()
CL-R-CT (Orange)

  • Assisted reproduction vitrification carrier

Cryolock(G) - B056CLRCTG1

Cryolock - Green Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
CL-R-CT(G)
In Commercial Distribution

  • B056CLRCTG2 ()
  • B056CLRCTG1 ()
  • B056CLRCTG0 ()
  • B056CLRCTG5 ()
  • B056CLRCTG3 ()
  • B056CLRCTG7 ()
CL-R-CT (Green)

  • Assisted reproduction vitrification carrier

CRYOLOCK(C) - B056CLRCTC1

Cryolock - Clear Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
CL-R-CT(C)
In Commercial Distribution

  • B056CLRCTC5 ()
  • B056CLRCTC2 ()
  • B056CLRCTC1 ()
  • B056CLRCTC0 ()
  • B056CLRCTC3 ()
  • B056CLRCTC7 ()
CL-R-CT (Clear)

  • Assisted reproduction vitrification carrier

Cryolock(B) - B056CLRCTB1

Cryolock - Blue Cryopreservation Storage Device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
CL-R-CT(B)
In Commercial Distribution

  • B056CLRCTB2 ()
  • B056CLRCTB1 ()
  • B056CLRCTB0 ()
  • B056CLRCTB5 ()
  • B056CLRCTB3 ()
  • B056CLRCTB7 ()
CL-R-CT (Blue)

  • Assisted reproduction vitrification carrier

Vitale - B492202670

Vitale Silicone Super-Absorbent Dressings, 6" x 7", 10/box, 10 boxes/case, 2 cases/overpack
CELLERA LLC
20267
Not in Commercial Distribution

  • B492202673 ()
  • B492202671 ()
  • B492202670 ()
  • B492202672 ()
  • B49220673 ()
20267

  • Exudate-absorbent dressing, non-gel, non-antimicrobial

Movement and Compressions System (MAC) - B547RF14100

MAC Controller
Recovery Force, LLC
H
In Commercial Distribution

  • B547RF14100 ()
  • B547RF144020 ()
  • B547RF144021 ()
  • B547RF144022 ()
  • B547RF1440230 ()

  • Length: 136 Millimeter
RF1410

  • Intermittent venous compression system
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