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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BB*SIE-ART-ZEE-SG-3, 3" ARTISZEE, OR MATTRESS, 2 PIECE
CASCO MANUFACTURING SOLUTIONS, INC.
92479
In Commercial Distribution

  • 00815073027775 ()
92479

  • Operating table mattress, basic
VALIDATE CM3 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual instrument systems for the following analytes: homocysteine (HCY) and lipoprotein (a) (LP(a)). Each test kit consists of one bottle each of Levels 1 through 5. Each bottle contains 3.0 milliliters. There exists a linear relationship among Levels 1 through 5.
Lgc Clinical Diagnostics, Inc.
409ro
In Commercial Distribution

  • 00850011135204 ()

  • 2 tests
409ro

  • Multiple cardiac marker IVD, control
  • Homocysteine IVD, control
Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood, Plasma, or Serum.
International Point of Care Incorporated
CS3002
Not in Commercial Distribution

  • B103A25CS30021 ()
  • B103CS30020 ()
CS3002

  • Multiple cardiac marker IVD, kit, rapid ICT, clinical
Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood, Plasma, or Serum.
International Point of Care Incorporated
CS3002
Not in Commercial Distribution

  • B103A20CS30021 ()
  • B103CS30020 ()
CS3002

  • Multiple cardiac marker IVD, kit, rapid ICT, clinical
Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood, Plasma, or Serum.
International Point of Care Incorporated
CS3002
Not in Commercial Distribution

  • B103A10CS30021 ()
  • B103CS30020 ()
CS3002

  • Multiple cardiac marker IVD, kit, rapid ICT, clinical
Pulsating, Low Air Loss, Battery Backup, Control Unit.
KAP MEDICAL
Wave BB
In Commercial Distribution

  • 00817012030839 ()
Wave BB

  • Low-air-loss bed
K-Z Alternating Rotation, True Low Air Loss, Battery Backup Control Unit
KAP MEDICAL
K-Z BB
In Commercial Distribution

  • 00817012023633 ()
K-Z BB

  • Low-air-loss bed
K-4 Alternating Pressure with True Low Air Loss and Battery Backup Control Unit
KAP MEDICAL
K-4 BB
In Commercial Distribution

  • 00817012023534 ()
K-4 BB

  • Low-air-loss bed
Wall-mounted storage box provides storage and immediate availability for emergency-use items such as oxygen masks, resuscitator bags, airways, masks, filters, etc. (The storage box does not include these items.) Dimensions: 20" Length x 8" Width x 6" Depth.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BB 4500-20D
In Commercial Distribution

  • M996BB450020D0 ()
BB 4500-20D

  • Medical device storage mount
Boil and Bite Home Impression Kit.
ORTHOFX
BB HIK
In Commercial Distribution

  • 00860003321775 ()


  • Wax dental impression material
  • Dental impression tray, single-use
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