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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JAPAN 18G X 1.5 RB HYPO NEEDLE
MEDLINE INDUSTRIES, INC.
SAMPCJ001
In Commercial Distribution

  • 10195327614676 ()
SAMPCJ001

  • General surgical procedure kit, non-medicated, single-use
JAPAN 20G X 1 RB HYPO NEEDLE
MEDLINE INDUSTRIES, INC.
SAMPCJ002
In Commercial Distribution

  • 10195327614775 ()
SAMPCJ002

  • General surgical procedure kit, non-medicated, single-use
Precision Systems OSMETTE XL osmometer, 105VAC, Japan
Precision Systems, Inc.
5007J
In Commercial Distribution

  • 00850041049199 ()
5007J

  • Osmometric analyser IVD
V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+
Respironics California, Inc.
1076709
In Commercial Distribution

  • 00884838033832 ()
1076709

  • Portable electric ventilator
ASSY, LTV1150, W/ ACC, GREY BTS, JAPAN
Carefusion Corporation
27552-006
Not in Commercial Distribution

  • 00845873004911 ()


  • Transport electric ventilator
ASSYM LTV1200, W/ ACC, GREY BTS, JAPAN
Carefusion Corporation
27553-006
Not in Commercial Distribution

  • 00845873004904 ()


  • Transport electric ventilator
FINAL ASSEMBLY, SPARK™ TRUCOLOR, TTL, JAPAN
METREX RESEARCH, LLC
910174-11
In Commercial Distribution

  • 00615375013250 ()


  • Surgical binoculars, reusable
MTO 6 LINE BOSTON SCIENTIFIC JAPAN PG
MEDLINE INDUSTRIES, INC.
62617001
In Commercial Distribution

  • 20193489057840 ()
  • 10193489057843 ()
62617001

  • Angiography kit
REMstar Auto A-Flex with SD Card, Japan
Respironics, Inc.
REMstar Auto A-Flex W/SD Card JP
Not in Commercial Distribution

  • 00606959030923 ()
JP566S

  • Home CPAP unit
EasyLife Mask with Headgear, Medium Wide, Japan
Respironics, Inc.
EasyLife Mask w/Headgear, Medium Wide, Japan
Not in Commercial Distribution

  • 00606959027862 ()
1050043

  • CPAP/BPAP nasal mask, reusable
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