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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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Alere NT-proBNP for Alinity Calibrator Kit - 05055845400534

The Alere NT-proBNP for Alinity i Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma. For additional information, refer to the Alere NT-proBNP for Alinity i reagent package insert and the Alinity ci-series Operations Manual.
AXIS-SHIELD DIAGNOSTICS LIMITED
04S7902
In Commercial Distribution

  • 05055845400534 ()
04S7902

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator

OR Pack sans Centrifugal Pump - 00607567211162

HMO 71000 (BO coated) Quadrox i Adult with integral filter, BO-VHK 71000 Venous Reservoir, Bacteria filter
DATASCOPE CORP.
BO-TOP 45603
Not in Commercial Distribution

  • 00607567211162 ()
709000289

  • Cardiopulmonary bypass system blood tubing set

Adult CPB Pack with VKMO 71000 - 00607567200418

HMO 71000 (BO coated) Quadrox i Adult with integral filter, BO-VHK 71000 Venous Reservoir, Gas Filter
DATASCOPE CORP.
BO-TOP 19000
Not in Commercial Distribution

  • 00607567200418 ()
701051874

  • Cardiopulmonary bypass system blood tubing set

b-ONE™ Primary Acetabular System - 00843575103567

Cementless Acetabular Shell, Cluster Hole; Porous Plasma Spray + HA Coating; 56mm Outer Diameter, Liner Size I
B-ONE ORTHO, CORP.
881311561I
In Commercial Distribution

  • 00843575103567 ()
881311561I

  • Metallic acetabulum prosthesis

Mini ONE® Balloon Button - 00842071120740

10FR x 4.0 cm Mini ONE® Balloon Button (Boxed Kit -I) Low Profile Feeding Device
APPLIED MEDICAL TECHNOLOGY, INC.
M1-5-1040-I
In Commercial Distribution

  • 00842071120740 ()

  • Catheter Gauge: 10 French
  • Length: 4.0 Centimeter
M1-5-1040-I

  • Gastrostomy button
  • Enteral feeding noninvasive-component set

Mini ONE® Balloon Button - 00842071120733

10FR x 3.5 cm Mini ONE® Balloon Button (Boxed Kit -I) Low Profile Feeding Device
APPLIED MEDICAL TECHNOLOGY, INC.
M1-5-1035-I
In Commercial Distribution

  • 00842071120733 ()

  • Catheter Gauge: 10 French
  • Length: 3.5 Centimeter
M1-5-1035-I

  • Gastrostomy button
  • Enteral feeding noninvasive-component set

Mini ONE® Balloon Button - 00842071120726

10FR x 3.0 cm Mini ONE® Balloon Button (Boxed Kit -I) Low Profile Feeding Device
APPLIED MEDICAL TECHNOLOGY, INC.
M1-5-1030-I
In Commercial Distribution

  • 00842071120726 ()

  • Catheter Gauge: 10 French
  • Length: 3.0 Centimeter
M1-5-1030-I

  • Gastrostomy button
  • Enteral feeding noninvasive-component set

Mini ONE® Balloon Button - 00842071120719

10FR x 2.7 cm Mini ONE® Balloon Button (Boxed Kit -I) Low Profile Feeding Device
APPLIED MEDICAL TECHNOLOGY, INC.
M1-5-1027-I
In Commercial Distribution

  • 00842071120719 ()

  • Length: 2.7 Centimeter
  • Catheter Gauge: 10 French
M1-5-1027-I

  • Gastrostomy button
  • Enteral feeding noninvasive-component set

Mini ONE® Balloon Button - 00842071120702

10FR x 2.5 cm Mini ONE® Balloon Button (Boxed Kit -I) Low Profile Feeding Device
APPLIED MEDICAL TECHNOLOGY, INC.
M1-5-1025-I
In Commercial Distribution

  • 00842071120702 ()

  • Length: 2.5 Centimeter
  • Catheter Gauge: 10 French
M1-5-1025-I

  • Gastrostomy button
  • Enteral feeding noninvasive-component set

Mini ONE® Balloon Button - 00842071120696

10FR x 2.3 cm Mini ONE® Balloon Button (Boxed Kit -I) Low Profile Feeding Device
APPLIED MEDICAL TECHNOLOGY, INC.
M1-5-1023-I
In Commercial Distribution

  • 00842071120696 ()

  • Length: 2.3 Centimeter
  • Catheter Gauge: 10 French
M1-5-1023-I

  • Gastrostomy button
  • Enteral feeding noninvasive-component set
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