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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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Somnostar - 10846446033328

CD, LabManager HL7 Hotfix
Carefusion Corporation
30862-001
Not in Commercial Distribution

  • 10846446033328 ()
30862-001

  • Home-use sleep apnoea recording system

Vmax - 10846446032734

CD,VMAX VER 28
Carefusion Corporation
23796-001
Not in Commercial Distribution

  • 10846446032734 ()
23796-001

  • Pulmonary function analysis system, adult
  • Pulmonary function analysis system, paediatric

NA - 00643169719972

SOFTWARE CD S0278-00 FITTING
MEDTRONIC XOMED, INC.
S0278-00
Not in Commercial Distribution

  • 00643169719972 ()


  • Audiometric/hearing device software

Medline Industries, Inc. - 10889942312504

LAPAROSCOPIC GASTRIC BYPASS CD
MEDLINE INDUSTRIES, INC.
CDS982608D
In Commercial Distribution

  • 10889942312504 ()
CDS982608D

  • General surgical procedure kit, medicated

PACS Scan CD - 00850677007112

PACS Scan Software CD
HYLAND LLC
5
In Commercial Distribution

  • 00850677007112 ()


  • Radiography digital imaging scanner

GEAR VIEW QC CD - 00850677007105

GEAR VIEW QC CD
HYLAND LLC
2
In Commercial Distribution

  • 00850677007105 ()


  • Radiological PACS software

Medline Industries, Inc. - 10889942874804

C-D & C HYSTEROSCOPY PACK
MEDLINE INDUSTRIES, INC.
DYNJ05112C
In Commercial Distribution

  • 10889942874804 ()
  • 40889942874805 ()
DYNJ05112C

  • General surgical procedure kit, non-medicated, single-use

ResScan - 00619498313365

ResScan V6.1 CD ASSY
RESMED PTY LTD
31336
In Commercial Distribution

  • 00619498313365 ()
31336

  • Ventilator application software

ResScan - 00619498313358

RESSCAN V6.0.2 CD ASSY
RESMED PTY LTD
31335
In Commercial Distribution

  • 00619498313358 ()
31335

  • Ventilator application software

ResScan - 00619498313341

RESSCAN V6.0.1 CD ASSY
RESMED PTY LTD
31334
In Commercial Distribution

  • 00619498313341 ()
31334

  • Ventilator application software
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