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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Medline Industries, Inc. - 10195327616038

JAPAN 1ML
MEDLINE INDUSTRIES, INC.
SAMPCJ005
In Commercial Distribution

  • 40195327616039 ()
  • 10195327616038 ()
SAMPCJ005

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

DPNCheck, Japan - 00851221006582

DPNCheck Device, Japan
NEUROMETRIX, INC.
NC-030-JFD
In Commercial Distribution

  • 00851221006582 ()


  • Diagnostic peripheral nerve electrical stimulation system

Alice PDX Assembly, JP - 00606959060401

Alice PDx Portable Sleep Diagnostic System, Japan
Respironics, Inc.
JAPAN
In Commercial Distribution

  • 00606959060401 ()
1047990X

  • Home-use sleep apnoea recording system

Medline Industries, Inc. - 10195327616946

JAPAN 20ML SYRINGE
MEDLINE INDUSTRIES, INC.
SAMPCJ009
In Commercial Distribution

  • 10195327616946 ()
SAMPCJ009

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

Medline Industries, Inc. - 10195327616892

JAPAN 60ML SYRINGE
MEDLINE INDUSTRIES, INC.
SAMPCJ011
In Commercial Distribution

  • 40195327616893 ()
  • 10195327616892 ()
SAMPCJ011

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

Medline Industries, Inc. - 10195327616809

JAPAN 30ML SYRINGE
MEDLINE INDUSTRIES, INC.
SAMPCJ010
In Commercial Distribution

  • 10195327616809 ()
SAMPCJ010

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

Medline Industries, Inc. - 10195327616427

JAPAN 10ML SYRINGE
MEDLINE INDUSTRIES, INC.
SAMPCJ008
In Commercial Distribution

  • 10195327616427 ()
SAMPCJ008

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

Medline Industries, Inc. - 10195327616410

JAPAN 5ML SYRINGE
MEDLINE INDUSTRIES, INC.
SAMPCJ007
In Commercial Distribution

  • 10195327616410 ()
SAMPCJ007

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

Medline Industries, Inc. - 10195327616304

JAPAN 3ML SYRINGE
MEDLINE INDUSTRIES, INC.
SAMPCJ006
In Commercial Distribution

  • 10195327616304 ()
SAMPCJ006

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

CoughAssist - 00606959005570

CoughAssist, E70, Japan
Respironics, Inc.
CoughAssist, E70, JP
Not in Commercial Distribution

  • 00606959005570 ()
1098163

  • Positive pressure airway secretion-clearing device

PHONATORY AERODYNAMIC SYSTEM - 04961333244645

NASOMETER II (JAPAN)
PENTAX OF AMERICA, INC.
6450-JP
In Commercial Distribution

  • 04961333244645 ()


  • Electroglottograph

VISI-PITCH - 04961333244621

VISI-PITCH IV (JAPAN)
PENTAX OF AMERICA, INC.
3950B-JP
In Commercial Distribution

  • 04961333244621 ()


  • Electroglottograph

BiPAP System One 60 Series - 00606959031845

BiPAP Auto, Japan
Respironics, Inc.
BiPAP Auto, JP
Not in Commercial Distribution

  • 00606959031845 ()
766P

  • Home BPAP unit

REMstar System One 60 Series - 00606959030831

REMstar Auto, Japan
Respironics, Inc.
REMstar Auto JP
Not in Commercial Distribution

  • 00606959030831 ()
566P

  • Home CPAP unit

REMstar System One 60 Series - 00606959030442

REMstar Pro, Japan
Respironics, Inc.
REMstar Pro, JP
Not in Commercial Distribution

  • 00606959030442 ()
466P

  • Home CPAP unit

EncoreAnywhere - 00606959054837

EncoreAnywhere - Japan Instance
Respironics, Inc.
2.40
In Commercial Distribution

  • 00606959054837 ()
1114981

  • Medical equipment clinical data interfacing software

EncoreAnywhere - 00606959053380

EncoreAnywhere - Japan Instance
Respironics, Inc.
2.39
In Commercial Distribution

  • 00606959053380 ()
1114981

  • Medical equipment clinical data interfacing software

Care Orchestrator - 00606959052420

Care Orchestrator Japan
Respironics, Inc.
1.15
In Commercial Distribution

  • 00606959052420 ()
1136532

  • Medical equipment clinical data interfacing software

EncoreAnywhere - 00606959052284

EncoreAnywhere - Japan Instance
Respironics, Inc.
2.38
In Commercial Distribution

  • 00606959052284 ()
1114981

  • Medical equipment clinical data interfacing software

Care Orchestrator - 00606959052222

Care Orchestrator Japan
Respironics, Inc.
1.14
In Commercial Distribution

  • 00606959052222 ()
1136532

  • Medical equipment clinical data interfacing software

Trilogy Evo, Japan - 00606959051973

Trilogy Evo, Japan
Respironics, Inc.
JP2110X16B
In Commercial Distribution

  • 00606959051973 ()
JP2110X16B

  • Portable electric ventilator

Care Orchestrator Japan - 00606959050693

Care Orchestrator Japan
Respironics, Inc.
1.13
In Commercial Distribution

  • 00606959050693 ()
1136532

  • Medical equipment clinical data interfacing software

Care Orchestrator Japan - 00606959050013

Care Orchestrator Japan
Respironics, Inc.
1.12
In Commercial Distribution

  • 00606959050013 ()
1136532

  • Medical equipment clinical data interfacing software

Care Orchestrator Japan - 00606959049727

Care Orchestrator Japan
Respironics, Inc.
1.11
In Commercial Distribution

  • 00606959049727 ()
1136532

  • Medical equipment clinical data interfacing software

Allied Medical LLC - 00026072000502

Demand Valve Japan.
Allied Medical, LLC
L063-070
In Commercial Distribution

  • 00026072000502 ()
L063-070

  • Demand valve

SmartVest - B102070124S3920

Supplement Kit (Japan)
ELECTROMED, INC.
SV2100-JPN
In Commercial Distribution

  • B102070124S3920 ()
SV2100-JPN

  • Chest-oscillation airway secretion-clearing system vest

PHB, Autoalert, Japan - Primary - 00884838071797

PHB, Autoalert, Japan - Primary
Lifeline Systems Company
1840501
Not in Commercial Distribution

  • 00884838071797 ()
FD100-J

  • Vulnerable patient home alert system

HUDSON RCI - 14026704728531

Conchatherm® Neptune - Japan
TELEFLEX INCORPORATED
IPN927525
In Commercial Distribution

  • 54026704728539 ()
  • 14026704728531 ()
425-40

  • Heated respiratory humidifier

OsteoMed - 00845694012782

AC Power Cord, Japan
OSTEOMED LLC
450-0537
In Commercial Distribution

  • 00845694012782 ()
450-0537

  • General internal orthopaedic fixation system implantation kit

PRI Cellular Modem - 00606959026704

PRI Cellular Modem, Japan
Respironics, Inc.
PRI Cellular Modem, JA
Not in Commercial Distribution

  • 00606959026704 ()
100230C

  • Clinical laboratory information system

Trilogy - 00606959025394

Trilogy O2 Ventilator, Japan
Respironics, Inc.
Trilogy O2 Ventilator Japan
Not in Commercial Distribution

  • 00606959025394 ()
1040004

  • Portable electric ventilator

Trilogy - 00606959025387

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

  • 00606959025387 ()
1054655

  • Portable electric ventilator

Trilogy - 00606959025370

Trilogy 200 Ventilator, Japan
Respironics, Inc.
Trilogy200 Ventilator, Japan
Not in Commercial Distribution

  • 00606959025370 ()
1032804

  • Portable electric ventilator

DreamStation - 00606959022881

DreamStation Cellular Modem, Japan
Respironics, Inc.
00
In Commercial Distribution

  • 00606959022881 ()
100630C

  • Clinical laboratory information system

I-neb - 00383730004396

I-neb PH Unit Japan
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
In Commercial Distribution

  • 00383730004396 ()
1080086

  • Ultrasonic nebulizing system

NASOMETER II - 04961333244638

COMPUTERIZED SPEECH LAB (JAPAN)
PENTAX OF AMERICA, INC.
4500-JP
In Commercial Distribution

  • 04961333244638 ()


  • Electroglottograph

Actiwatch Spectrum Plus - 00606959042049

Actiwatch Spectrum Plus Japan
Respironics, Inc.
Actiwatch Spectrum Plus, Japan
Not in Commercial Distribution

  • 00606959042049 ()
JP1101894

  • Kinesiology ambulatory recorder

Actiwatch Spectrum Pro - 00606959042032

Actiwatch Spectrum PRO Japan
Respironics, Inc.
Actiwatch Spectrum PRO Japan
Not in Commercial Distribution

  • 00606959042032 ()
JP1099351

  • Kinesiology ambulatory recorder

DreamStation - 00606959033368

DreamStation Heated Humidifier, Japan
Respironics, Inc.
DreamStation Heated Humidifier, JP
Not in Commercial Distribution

  • 00606959033368 ()
JPXH

  • Heated respiratory humidifier

OmniLab Advanced Plus - 00606959032040

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

  • 00606959032040 ()
1109585

  • Portable electric ventilator
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