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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FitLife - 00606959023048

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

  • 00606959023048 ()
1089996

  • CPAP/BPAP face mask, reusable

DreamStation Go - 00606959048706

DreamStation Go Auto CPAP with Bluetooth, Japan
Respironics, Inc.
DreamStation Go Auto CPAP with Bluetooth, JP
Not in Commercial Distribution

  • 00606959048706 ()
JPG500S16

  • Home CPAP unit

DreamStation BiPAP autoSV - 00606959045415

DreamStation BiPAP autoSV with cellular modem, Japan
Respironics, Inc.
DreamStation BiPAP autoSV W/Cell, JP
Not in Commercial Distribution

  • 00606959045415 ()
JPX900S16C

  • Portable electric ventilator

ComfortGel Blue - 00606959043909

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

  • 00606959043909 ()
1081843

  • CPAP/BPAP face mask, reusable

BiPAP A40 - 00606959042797

BiPAP A40 Silver Series FGD SA, Japan
Respironics, Inc.
00
In Commercial Distribution

  • 00606959042797 ()
1109601

  • Portable electric ventilator

NUANCE - 00606959041905

Nuance Gel Pillows Mask with headgear, Japan
Respironics, Inc.
Nuance Gel Pillows Mask with headgear, Japan
Not in Commercial Distribution

  • 00606959041905 ()
1105162

  • CPAP/BPAP nasal mask, reusable

PN841 - 00606959041622

PN841 Mask, Child Large, Leak 3, Japan
Respironics, Inc.
PN841 Mask, JPN, Child Large, Leak 3, ASM
In Commercial Distribution

  • 30606959041623 ()
  • 00606959041622 ()
1130560

  • CPAP/BPAP nasal mask, single-use

PN841 - 00606959041615

PN841 Mask, Child Med, Leak 3, Japan
Respironics, Inc.
PN841 Mask, JPN, Child Med, Leak 3, ASM
In Commercial Distribution

  • 30606959041616 ()
  • 00606959041615 ()
1130558

  • CPAP/BPAP nasal mask, single-use

PN841 - 00606959041608

PN841 Mask, Child Small, Leak 3, Japan
Respironics, Inc.
PN841 Mask, JPN, Child Small, Leak 3, ASM
Not in Commercial Distribution

  • 30606959041609 ()
  • 00606959041608 ()
1130496

  • CPAP/BPAP nasal mask, single-use

PN841 - 00606959041592

PN841, Child Large, with Standard Elbow, Japan
Respironics, Inc.
PN841 Mask, JPN, Child Large, SE, Single Use
In Commercial Distribution

  • 00606959041592 ()
1130572

  • CPAP/BPAP nasal mask, single-use

A Series - 00606959041028

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

  • 00606959041028 ()
1111553

  • Heated respiratory humidifier

Alice PDx - 00606959039032

Alice PDx Core System, without Sensors, Japan
Respironics, Inc.
Alice PDx Core System without Sensors, JP
Not in Commercial Distribution

  • 00606959039032 ()
1058373

  • Polysomnograph

ALICE PDx - 00606959038813

Alice PDx Portable Sleep Diagnostic System, Japan
Respironics, Inc.
Alice PDx Sleep Diagnostic System, JP
Not in Commercial Distribution

  • 00606959038813 ()
1047990

  • Polysomnograph

OmniLab Advanced Plus - 00606959038127

BiPAP Hybrid A30 Ventilator with Humidifier, Japan
Respironics, Inc.
BiPAP Hybrid A30 Ventilator with Humidifier, Japan
Not in Commercial Distribution

  • 00606959038127 ()
1111182

  • Portable electric ventilator

A Series - 00606959032057

BiPAP A Series, System One Humidifier, Japan
Respironics, Inc.
BiPAP A Series, System One Humidifier, JP
Not in Commercial Distribution

  • 00606959032057 ()
1111515

  • Heated respiratory humidifier

REMstar System (60 Series) - 00606959031869

BiPAP Auto BiFlex, with SD Card, Japan
Respironics, Inc.
BiPAP Auto BiFlex, System One 60 Series, JP
Not in Commercial Distribution

  • 00606959031869 ()
JP766S

  • Home BPAP unit

REMstar System One 60 Series - 00606959030923

REMstar Auto A-Flex with SD Card, Japan
Respironics, Inc.
REMstar Auto A-Flex W/SD Card JP
Not in Commercial Distribution

  • 00606959030923 ()
JP566S

  • Home CPAP unit

EASYLIFE - 00606959027862

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

  • 00606959027862 ()
1050043

  • CPAP/BPAP nasal mask, reusable

Spark TruColor - 00615375013250

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

  • 00615375013250 ()


  • Surgical binoculars, reusable

LTV - 00845873004911

ASSY, LTV1150, W/ ACC, GREY BTS, JAPAN
Carefusion Corporation
27552-006
Not in Commercial Distribution

  • 00845873004911 ()


  • Transport electric ventilator
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