SEARCH RESULTS FOR: ("Japan enterprise-signed app-TG:@crmeb8🆑testflight-signed app.dcf")(774 results)

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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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Trilogy 100 - 00606959052345

Trilogy 100 Ventilator, w/ Bluetooth, Japan
Respironics, Inc.
Trilogy 100 Ventilator, w/ Bluetooth, Japan
Not in Commercial Distribution

  • 00606959052345 ()
1054655B

  • Portable electric ventilator

FITLIFE - 00606959023031

FitLife Mask with Headgear, Large, Japan
Respironics, Inc.
FitLife Mask with Headgear, Large, Japan
Not in Commercial Distribution

  • 00606959023031 ()
1060806

  • CPAP/BPAP face mask, reusable

FITLIFE - 00606959023024

FitLife Mask with Headgear, Small, Japan
Respironics, Inc.
FitLife Mask with Headgear, Small, Japan
Not in Commercial Distribution

  • 00606959023024 ()
1060805

  • CPAP/BPAP face mask, reusable

PerforMax - 00606959011861

PerforMax Disposable SE SA, Japan, Small
Respironics, Inc.
00
In Commercial Distribution

  • 30606959011862 ()
  • 00606959011861 ()
1055002

  • CPAP/BPAP face mask, single-use

Invasive Circuit - 00606959049802

Inv Circuit Assembly Single – Japan
Respironics, Inc.
00
In Commercial Distribution

  • 30606959049803 ()
  • 00606959049802 ()
1136819

  • Ventilator breathing circuit, single-use

DreamStation - 00606959048973

DreamStation Cellular Modem with Oximetry, Japan
Respironics, Inc.
DreamStation Cellular Modem with Oximetry, JP
Not in Commercial Distribution

  • 00606959048973 ()
100630C

  • Clinical laboratory information system

ComfortGel Blue - 00606959043893

ComfortGel Blue Full Mask, Large, Japan
Respironics, Inc.
ComfortGel Blue Full Mask, Large, Japan
Not in Commercial Distribution

  • 00606959043893 ()
1081842

  • CPAP/BPAP face mask, reusable

ComfortGel Blue - 00606959043886

ComfortGel Blue Full Mask, Medium, Japan
Respironics, Inc.
ComfortGel Blue Full Mask, Medium, Japan
Not in Commercial Distribution

  • 00606959043886 ()
1081841

  • CPAP/BPAP face mask, reusable

ComfortGel Blue - 00606959043879

ComfortGel Blue Full Mask, Small, Japan
Respironics, Inc.
ComfortGel Blue Full Mask, Small, Japan
Not in Commercial Distribution

  • 00606959043879 ()
1081840

  • CPAP/BPAP face mask, reusable

OmniLab Advanced Plus - 00606959038134

BiPAP Hybrid A30 Ventilator, SpO2, Japan
Respironics, Inc.
BiPAP Hybrid A30 Ventilator, SpO2, JP
Not in Commercial Distribution

  • 00606959038134 ()
1111153

  • Portable electric ventilator

DreamStation - 00606959037540

DreamStation Cellular Modem with Oximetry, Japan
Respironics, Inc.
DreamStation, Cellular Modem with Oximetry, JP
Not in Commercial Distribution

  • 00606959037540 ()
200630C

  • Medical networking interface unit

DreamStation - 00606959034785

DreamStation Auto BiPAP with Cellular, Japan
Respironics, Inc.
DreamStation Auto BiPAP w/Cell, JP
Not in Commercial Distribution

  • 00606959034785 ()
JPX700S16C

  • Home BPAP unit

DreamStation - 00606959034778

DreamStation Auto CPAP with Cellular, Japan
Respironics, Inc.
DreamStation Auto CPAP w/Cell, JP
Not in Commercial Distribution

  • 00606959034778 ()
JPX500S16C

  • Home CPAP unit

DreamStation - 00606959034761

DreamStation CPAP Pro with Cell, Japan
Respironics, Inc.
DreamStation CPAP Pro w/Cell, JP
Not in Commercial Distribution

  • 00606959034761 ()
JPX400S16C

  • Home CPAP unit

Trilogy 100 Ventilator, Japan, Recertified - 00606959033955

Trilogy 100 Ventilator, Recertified, Japan version
Respironics, Inc.
00
In Commercial Distribution

  • 00606959033955 ()
U1054655

  • Portable electric ventilator

Trilogy 200 - 00606959033863

Trilogy 200 Ventilator, Rental, Japan version
Respironics, Inc.
Trilogy 200 Ventilator, Japan-Rental
Not in Commercial Distribution

  • 00606959033863 ()
R1032804

  • Portable electric ventilator

Alice 6 - 00606959033764

Alice 6 Base Station, LDx, Japan
Respironics, Inc.
Alice 6 Base Station, LDx, Japan
Not in Commercial Distribution

  • 00606959033764 ()
JP1063315

  • Polysomnograph

Alice 6 - 00606959033757

Alice 6 Base Station, LDE, Japan
Respironics, Inc.
Alice 6 Base Station, LDE, Japan
Not in Commercial Distribution

  • 00606959033757 ()
JP1063312

  • Polysomnograph

Alice PDx - 00606959033580

Alice PDx, ECG Yoke Cable, Japan
Respironics, Inc.
Alice PDx ECG Yoke, JP
Not in Commercial Distribution

  • 00606959033580 ()
1048916

  • Polysomnograph

OmniLab Advanced Plus - 00606959029453

OmniLab Advanced Plus with Humidifier, Japan
Respironics, Inc.
OmniLab Advanced Plus with Humidifier, JP
Not in Commercial Distribution

  • 00606959029453 ()
1111139

  • Portable electric ventilator

System One - 00606959029255

System One Heated Tube Humidifier, Japan
Respironics, Inc.
System One Heated Tube Humidifier, JP
Not in Commercial Distribution

  • 00606959029255 ()
JP6T

  • Heated respiratory humidifier

EASYLIFE - 00606959027879

EasyLife Mask with Headgear, Large, Japan
Respironics, Inc.
EasyLife Mask w/Headgear, Large, Japan
Not in Commercial Distribution

  • 00606959027879 ()
1050044

  • CPAP/BPAP nasal mask, reusable

EASYLIFE - 00606959027855

EasyLife Mask w/Headgear, Medium, Japan
Respironics, Inc.
EasyLife Mask w/Headgear, Medium, Japan
Not in Commercial Distribution

  • 00606959027855 ()
1050042

  • CPAP/BPAP nasal mask, reusable

EASYLIFE - 00606959027848

EasyLife Mask w/Headgear, Small, Japan
Respironics, Inc.
EasyLife Mask w/Headgear, Small, Japan
Not in Commercial Distribution

  • 00606959027848 ()
1050041

  • CPAP/BPAP nasal mask, reusable

EASYLIFE - 00606959027831

EasyLife Mask w/Headgear, Petite, Japan
Respironics, Inc.
EasyLife Mask w/Headgear, Petite, Japan
Not in Commercial Distribution

  • 00606959027831 ()
1050040

  • CPAP/BPAP nasal mask, reusable

Natus - 05713315009051

Aurical Freefit without charger (Japan only)
Natus Medical Denmark ApS
8-62-45300
In Commercial Distribution

  • 05713315009051 ()


  • Hearing aid tester, electrical

Medline Industries, Inc. - 10195327615864

JAPAN 25G 1.5 RB HYPO NEEDLE
MEDLINE INDUSTRIES, INC.
SAMPCJ004
In Commercial Distribution

  • 10195327615864 ()
SAMPCJ004

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

EndoVue - 00818089022956

ENDOVUE, 24", AMERICAS, JAPAN, EMEA, BC-WU24-N1418
Nds Surgical Imaging LLC
90K0076
Not in Commercial Distribution

  • 00818089022956 ()


  • Image display unit, colour

EndoVue - 00818089022949

ENDOVUE, 21", AMERICAS, JAPAN, EMEA, BC-WU21-N1418
Nds Surgical Imaging LLC
90K0066
Not in Commercial Distribution

  • 00818089022949 ()


  • Image display unit, colour

Canister HFO-R1234 ZE / 950g, ALUM (Japan) - 00817495024905

Canister HFO-R1234 ZE / 950g, ALUM (Japan)
Candela Corporation
FIN101100
In Commercial Distribution

  • 00817495024905 ()


  • Dermatological solid-state laser system

InnoSpire Mini - 00383730002019

InnoSpire Mini w SS+ (Japan), 6-pack
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
In Commercial Distribution

  • 00383730002019 ()
1109293

  • Benchtop nebulizer, non-heated

Halyard - 20680651775096

ACMF JAPAN A PACK BLUE 25
O&M HALYARD, INC.
77509
In Commercial Distribution

  • 20680651775096 ()
  • 30680651775093 ()


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

PlasmaJet Neutral Plasma Surgery System - M397PS102130JP0

PlasmaJet V3 Plus Console System (Japan)
PLASMA SURGICAL, INC
PS10-2130-JP
In Commercial Distribution

  • M397PS102130JP0 ()
PS10-2130-JP

  • Plasma surgical system

Digitest™ - 00810000520657

Digitest™ II Digital Pulptester (Japan)
PARKELL, INC.
D640E-JM
In Commercial Distribution

  • 00810000520657 ()
D640E-JM

  • Dental pulp analysis system

PlasmaJet Neutral Plasma Surgery System - M397PS103130JP0

PlasmaJet Ultra Plus Console System (Japan)
PLASMA SURGICAL, INC
PS10-3130-JP
In Commercial Distribution

  • M397PS103130JP0 ()
PS10-3130-JP

  • Plasma surgical system

NuVasive - 00887517061522

Universal Base, Japan Implant Case Small
Nuvasive, Inc.
7241004
In Commercial Distribution

  • 00887517061522 ()


  • Device sterilization/disinfection container, reusable

Model 4000 - 15099169402635

4000 RESPIRATORY MONITOR COPD-6 JAPAN HI-CHECKER
VITALOGRAPH (IRELAND) LIMITED
4000
In Commercial Distribution

  • 05099169402638 ()
  • 15099169402635 ()
  • 35099169402639 ()


  • Expiratory peak flow meter, digital

NAMIC - 10193489057843

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

  • 20193489057840 ()
  • 10193489057843 ()
62617001

  • Angiography kit

Spark TruColor - 00615375013250

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

  • 00615375013250 ()


  • Surgical binoculars, reusable

SPEC 3 - D661600139450

SPEC 3 LED Japan Plug Type AJ
COLTENE/WHALEDENT INC
60013945
In Commercial Distribution

  • D661600139450 ()


  • Dental/surgical polymerization lamp
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