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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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A&D - 00862492000346

Optum Homecare Portal W/BP
OPTUMHEALTH CARE SOLUTIONS, INC.
UA651BLE
Not in Commercial Distribution

  • 00862492000346 ()
AAA-00007

  • Self-care monitoring/reporting software

A&D - 00862492000339

Optum Home BP I-Apollo
OPTUMHEALTH CARE SOLUTIONS, INC.
UA651BLE
Not in Commercial Distribution

  • 00862492000339 ()
AAA-80013

  • Self-care monitoring/reporting software

Portal 724 - 00862492000322

Optum Home Scale I-ICUE
OPTUMHEALTH CARE SOLUTIONS, INC.
EM724BT
Not in Commercial Distribution

  • 00862492000322 ()
AAA-85009

  • Self-care monitoring/reporting software

Portal 724 - 00862492000315

Optum Home Scale I-Apollo
OPTUMHEALTH CARE SOLUTIONS, INC.
EM724BT
Not in Commercial Distribution

  • 00862492000315 ()
AAA-80012

  • Self-care monitoring/reporting software

Sonic - 05714464133864

SONIC EXPRESSFITPRO 2024.1
Sbo Hearing A/S
269332
In Commercial Distribution

  • 05714464133864 ()


  • Audiometric/hearing device software

Philips - 05714464131938

PHILIPS HEARSUITE 2024.1 TRO
Sbo Hearing A/S
268338
In Commercial Distribution

  • 05714464131938 ()


  • Audiometric/hearing device software

Neutral - 05714464131921

OASISNXT CUSTOM 2024.1
Sbo Hearing A/S
268337
In Commercial Distribution

  • 05714464131921 ()


  • Audiometric/hearing device software

Bernafon - 05714464131914

BERNAFON OASISNXT 2024.1
Sbo Hearing A/S
268336
In Commercial Distribution

  • 05714464131914 ()


  • Audiometric/hearing device software

Philips - 05714464131907

PHILIPS HEARSUITE 2024.1
Sbo Hearing A/S
268335
In Commercial Distribution

  • 05714464131907 ()


  • Audiometric/hearing device software

Oticon - 05714464131891

AUDIGYFIT 2 2024.1
Sbo Hearing A/S
268334
In Commercial Distribution

  • 05714464131891 ()


  • Audiometric/hearing device software

Oticon - 05714464131860

OTICON GENIE 2 2024.1 VA
Sbo Hearing A/S
268331
In Commercial Distribution

  • 05714464131860 ()


  • Audiometric/hearing device software

Oticon - 05714464131846

OTICON GENIE 2 2024.1
Sbo Hearing A/S
268329
In Commercial Distribution

  • 05714464131846 ()


  • Audiometric/hearing device software

Oticon - 05714464122615

AUDIGYFIT 2 2023.2
Sbo Hearing A/S
262883
In Commercial Distribution

  • 05714464122615 ()


  • Audiometric/hearing device software

Oticon - 05714464122561

OTICON GENIE 2 2023.2 VA
Sbo Hearing A/S
262878
In Commercial Distribution

  • 05714464122561 ()


  • Audiometric/hearing device software

Oticon - 05714464122554

OTICON GENIE 2 2023.2
Sbo Hearing A/S
262877
In Commercial Distribution

  • 05714464122554 ()


  • Audiometric/hearing device software

Sonic - 05714464122547

SONIC EXPRESSFITPRO 2023.2
Sbo Hearing A/S
262876
In Commercial Distribution

  • 05714464122547 ()


  • Audiometric/hearing device software

Philips - 05714464122530

PHILIPS HEARSUITE 2023.2 TRO
Sbo Hearing A/S
262875
In Commercial Distribution

  • 05714464122530 ()


  • Audiometric/hearing device software

Philips - 05714464122523

PHILIPS HEARSUITE 2023.2
Sbo Hearing A/S
262874
In Commercial Distribution

  • 05714464122523 ()


  • Audiometric/hearing device software

Bernafon - 05714464122516

BERNAFON OASISNXT 2023.2
Sbo Hearing A/S
262873
In Commercial Distribution

  • 05714464122516 ()


  • Audiometric/hearing device software

Bernafon - 05714464122509

OASISNXT CUSTOM 2023.2
Sbo Hearing A/S
262872
In Commercial Distribution

  • 05714464122509 ()


  • Audiometric/hearing device software
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