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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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Philips Sonicare - 08710103988984

Software, Sonicare Power Tooth brush, Web download App Android
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988984 ()


  • Basic electric toothbrush

Philips Sonicare - 08710103988977

Software, Sonicare Power Tooth brush, Web download App iOS
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988977 ()


  • Basic electric toothbrush

DRIVEMEDICAL - 00822383577173

Pressure PreventionBlank Product Description: Balanced Aire APP Mattress Custom
Drive Devilbiss Healthcare
BA9600-CUSTOM
In Commercial Distribution

  • 00822383577173 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable

FIBRIJET - 00815634020191

SPRAY SET ENDOSCOPIC APP. 5MMX40 CM, 11:1 RATIO
Micromedics, Inc.
SA-3658
In Commercial Distribution

  • 00815634020191 ()
  • 10815634020198 ()
  • 20815634020195 ()


  • Open-surgery adhesive/sealant applicator, dual-channel

FIBRIJET - 00815634020177

SPRAY SET ENDOSCOPIC APP. 5MMX30 CM, 11:1 RATIO
Micromedics, Inc.
SA-3657
In Commercial Distribution

  • 00815634020177 ()
  • 10815634020174 ()
  • 20815634020171 ()


  • Open-surgery adhesive/sealant applicator, dual-channel

DreamMapper - 00606959054240

DreamMapper Mobile App Android, Asia- Pacific Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054240 ()
1127960

  • Self-care monitoring/reporting software

DreamMapper - 00606959054226

DreamMapper Mobile App Android, North America Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054226 ()
1101479

  • Self-care monitoring/reporting software

Dexcom Follow App for iOS - 00386270001931

US Dexcom Follow App for iOS, (mg/dL), v4
Dexcom, Inc.
SW10497
In Commercial Distribution

  • 00386270001931 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Dexcom Follow App for Android - 00386270001917

US Dexcom Follow App for Android (mg/dL), v4
Dexcom, Inc.
SW10583
In Commercial Distribution

  • 00386270001917 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Medline - 30080196669886

DBD-PUMP, APP W/PAD, AERO PULSE, 31" X 6
MEDLINE INDUSTRIES, INC.
MSC80700A
In Commercial Distribution

  • 30080196669886 ()
MSC80700A

  • Alternating-pressure inflator

Cora - 00810042481893

Tampons, Retail, App. Reg.25/Super 10/Super+ 10
Cora
02Tampons-322
In Commercial Distribution

  • 00850373007041 ()
  • 00810042481893 ()


  • Menstrual tampon, unscented

Nihon Kohden - 06946725526668

Nihon Kohden Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1411-SR144PU
In Commercial Distribution

  • 06946725526668 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526651

Nihon Kohden Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1411-SW144PU
In Commercial Distribution

  • 06946725526651 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526644

Nihon Kohden Compatible Reusable SpO2 Sensor, Pediatric Soft Tip
APK Technology Co.,Ltd.
A1411-SP144PU
In Commercial Distribution

  • 06946725526644 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526637

Nihon Kohden Compatible Reusable SpO2 Sensor, Adult Soft Tip
APK Technology Co.,Ltd.
A1411-SA144PU
In Commercial Distribution

  • 06946725526637 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526620

Nihon Kohden Compatible Reusable SpO2 Sensor, Pediatric Finger
APK Technology Co.,Ltd.
A1411-SP144PV
In Commercial Distribution

  • 06946725526620 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526613

Nihon Kohden Compatible Reusable SpO2 Sensor, Adult Finger
APK Technology Co.,Ltd.
A1411-SA144PV
In Commercial Distribution

  • 06946725526613 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526606

Nihon Kohden Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1411-SR116PU
In Commercial Distribution

  • 06946725526606 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526590

Nihon Kohden Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1411-SW116PU
In Commercial Distribution

  • 06946725526590 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526583

Nihon Kohden Compatible Reusable SpO2 Sensor, Pediatric Soft Tip
APK Technology Co.,Ltd.
A1411-SP116PU
In Commercial Distribution

  • 06946725526583 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526576

Nihon Kohden Compatible Reusable SpO2 Sensor, Adult Soft Tip
APK Technology Co.,Ltd.
A1411-SA116PU
In Commercial Distribution

  • 06946725526576 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526569

Nihon Kohden Compatible Reusable SpO2 Sensor, Pediatric Finger
APK Technology Co.,Ltd.
A1411-SP116PV
In Commercial Distribution

  • 06946725526569 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526552

Nihon Kohden Compatible Reusable SpO2 Sensor, Adult Finger
APK Technology Co.,Ltd.
A1411-SA116PV
In Commercial Distribution

  • 06946725526552 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526545

Nihon Kohden Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1411-SR203PU
In Commercial Distribution

  • 06946725526545 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526538

Nihon Kohden Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1411-SR136PU
In Commercial Distribution

  • 06946725526538 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526521

Nihon Kohden Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1411-SR103PU
In Commercial Distribution

  • 06946725526521 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526514

Nihon Kohden Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1411-SW203PU
In Commercial Distribution

  • 06946725526514 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526507

Nihon Kohden Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1411-SW136PU
In Commercial Distribution

  • 06946725526507 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526491

Nihon Kohden Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1411-SW103PU
In Commercial Distribution

  • 06946725526491 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526484

Nihon Kohden Compatible Reusable SpO2 Sensor, Pediatric Soft Tip
APK Technology Co.,Ltd.
A1411-SP203PU
In Commercial Distribution

  • 06946725526484 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526477

Nihon Kohden Compatible Reusable SpO2 Sensor, Pediatric Soft Tip
APK Technology Co.,Ltd.
A1411-SP136PU
In Commercial Distribution

  • 06946725526477 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526460

Nihon Kohden Compatible Reusable SpO2 Sensor, Pediatric Soft Tip
APK Technology Co.,Ltd.
A1411-SP103PU
In Commercial Distribution

  • 06946725526460 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526453

Nihon Kohden Compatible Reusable SpO2 Sensor, Adult Soft Tip
APK Technology Co.,Ltd.
A1411-SA203PU
In Commercial Distribution

  • 06946725526453 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526446

Nihon Kohden Compatible Reusable SpO2 Sensor, Adult Soft Tip
APK Technology Co.,Ltd.
A1411-SA136PU
In Commercial Distribution

  • 06946725526446 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526439

Nihon Kohden Compatible Reusable SpO2 Sensor, Adult Soft Tip
APK Technology Co.,Ltd.
A1411-SA103PU
In Commercial Distribution

  • 06946725526439 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526422

Nihon Kohden Compatible Reusable SpO2 Sensor, Pediatric Finger
APK Technology Co.,Ltd.
A1411-SP203PV
In Commercial Distribution

  • 06946725526422 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526415

Nihon Kohden Compatible Reusable SpO2 Sensor, Pediatric Finger
APK Technology Co.,Ltd.
A1411-SP136PV
In Commercial Distribution

  • 06946725526415 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526408

Nihon Kohden Compatible Reusable SpO2 Sensor, Pediatric Finger
APK Technology Co.,Ltd.
A1411-SP103PV
In Commercial Distribution

  • 06946725526408 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526392

Nihon Kohden Compatible Reusable SpO2 Sensor, Adult Finger
APK Technology Co.,Ltd.
A1411-SA203PV
In Commercial Distribution

  • 06946725526392 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526385

Nihon Kohden Compatible Reusable SpO2 Sensor, Adult Finger
APK Technology Co.,Ltd.
A1411-SA136PV
In Commercial Distribution

  • 06946725526385 ()


  • Pulse Co-oximeter probe, reusable

Nihon Kohden - 06946725526378

Nihon Kohden Compatible Reusable SpO2 Sensor, Adult Finger
APK Technology Co.,Ltd.
A1411-SA103PV
In Commercial Distribution

  • 06946725526378 ()


  • Pulse Co-oximeter probe, reusable

HP - 06946725520499

No Description
APK Technology Co.,Ltd.
A0816-SA106PU
In Commercial Distribution

  • 06946725520499 ()
  • 16946725597948 ()


  • Pulse Co-oximeter probe, reusable

GE-Nellcor - 06946725523766

Nellcor Compatible Reusable SpO2 Sensor, Wrapping
APK Technology Co.,Ltd.
A1418-SW203PU
In Commercial Distribution

  • 06946725523766 ()


  • Pulse Co-oximeter probe, reusable

GE-Nellcor - 06946725523759

Nellcor Compatible Reusable SpO2 Sensor, Pediatric Soft Tip
APK Technology Co.,Ltd.
A1418-SP203PU
In Commercial Distribution

  • 06946725523759 ()


  • Pulse Co-oximeter probe, reusable

GE-Nellcor - 06946725523742

Nellcor Compatible Reusable SpO2 Sensor, Pediatric Finger Clip
APK Technology Co.,Ltd.
A1418-SP203PV
In Commercial Distribution

  • 06946725523742 ()


  • Pulse Co-oximeter probe, reusable

GE-Nellcor - 06946725523735

Nellcor Compatible Reusable SpO2 Sensor, Adult Soft Tip
APK Technology Co.,Ltd.
A1418-SA203PU
In Commercial Distribution

  • 06946725523735 ()


  • Pulse Co-oximeter probe, reusable

GE-Nellcor - 06946725523728

Nellcor Compatible Reusable SpO2 Sensor, Adult Finger Clip
APK Technology Co.,Ltd.
A1418-SA203PV
In Commercial Distribution

  • 06946725523728 ()


  • Pulse Co-oximeter probe, reusable

Kontron - 06946725554357

Datascope Trio Compatible Oximax Direct Connect Ear Clip Sensor
APK Technology Co.,Ltd.
10306
In Commercial Distribution

  • 06946725554357 ()


  • Tissue saturation oximeter sensor, reprocessed

Nihon Kohden - 06946725538869

Compatible with GE, 3 Lead Grouped ECG lead wires,Pinch,AHA
APK Technology Co.,Ltd.
A3157-EL1-001
In Commercial Distribution

  • 06946725538869 ()


  • Electrocardiographic lead set, reusable

GE - 06946725529942

GE Apex Pro FH-Philips 5L ECG Adapter
APK Technology Co.,Ltd.
A-CO-190
In Commercial Distribution

  • 16946725590789 ()
  • 06946725529942 ()
  • 16946725590956 ()


  • Electrocardiographic lead set, reusable
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