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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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DreamMapper Web (EMEA)
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959042001 ()
1128262

  • Self-care monitoring/reporting software
DreamMapper Web (APAC)
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959041974 ()
1127937

  • Self-care monitoring/reporting software
Foot Web Spacer
Gottfried Medical, Inc.
022
In Commercial Distribution

  • G420022 ()
022

  • Compression/pressure glove
LRF Web Application
Stryker GmbH
983031
In Commercial Distribution

  • 07613327297751 ()
983031

  • CAD/CAM software
ArthrexVIP Web Portal
ARTHREX, INC.
5566VIP
In Commercial Distribution

  • 00888867264953 ()
5566VIP

  • Orthopaedic/craniofacial implantation planning software
Web based software
MYCARDIO LLC
8
Not in Commercial Distribution

  • B315SLEEPIMAGECOM0 ()


  • Multiple physiological signal amplifier
Holter Web Portal
Lifesignals, Inc.
UA2251-C
In Commercial Distribution

  • B353UA2251C1 ()


  • Wireless patient monitor/sensor reporting software, professional-only
Touchscreen tablet computer configured with Nova-Link app for use with OtoNova Pro. Android/Windows/iPadOS as per customer requirement.
OTODYNAMICS LIMITED
NOVA-TABLET
In Commercial Distribution

  • 05060396171512 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
KIT, COMMON SPIRO
Cardinal Health 200, LLC
SPK692448E
In Commercial Distribution

  • 50888439347751 ()
  • 10888439347753 ()
SPK692448E

  • General surgical procedure kit, non-medicated, single-use
KIT, COMMON SPIRO
Cardinal Health 200, LLC
SPK692448F
In Commercial Distribution

  • 50888439537831 ()
  • 10888439537833 ()
SPK692448F

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