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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Mobile App utilized in the PDM (Personal Device Manager) for Dash Insulin pump secondary display. PDM Device 18239; app 41252
Insulet Corporation
1.3.1
In Commercial Distribution

  • 10385081120265 ()
18239

  • Ambulatory insulin infusion pump software, data-display
For the wireless mode version of the subject device, to be used in combination with an application installed on a tablet, the SPM01K3 convenience kit includes: 1 electrostimulator SPM01M1 configuration; electrodes; protective skin, and 1 tablet with the MySPM mobile application (SPM01A1).
NCS LAB SRL
SPM01K3
In Commercial Distribution

  • 08051122040964 ()
SPM01K3

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
CURBELL MEDICAL PRODUCTS, INC.
Rego Safe Mobility App
In Commercial Distribution

  • 00840828192095 ()


  • Inpatient motion surveillance software
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3537
In Commercial Distribution

  • 00301933537015 ()
85498754

  • Self-care monitoring/reporting software
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3536
In Commercial Distribution

  • 00301933536018 ()
85498770

  • Self-care monitoring/reporting software
for iOS
COCHLEAR LIMITED
NSA-1 / v5
In Commercial Distribution

  • 09321502062206 ()
P1834114

  • Audiometric/hearing device software
for Android
COCHLEAR LIMITED
NSA-2 / v5
In Commercial Distribution

  • 09321502062190 ()
P1834165

  • Audiometric/hearing device software
for iOS
COCHLEAR LIMITED
NSA-1 / v4
In Commercial Distribution

  • 09321502060486 ()
P1787372

  • Audiometric/hearing device software
for Android
COCHLEAR LIMITED
NSA-2 / v4
In Commercial Distribution

  • 09321502060479 ()
P1787373

  • Audiometric/hearing device software
DreamMapper iOS APAC Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051355 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper iOS EU Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051348 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper iOS APAC Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049956 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper iOS EU Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049949 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper iOS APAC Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution

  • 00606959049109 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper iOS EU Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution

  • 00606959049093 ()
1128264

  • Self-care monitoring/reporting software
The SEER 1000 Apple App is a software product which is an accessory to the SEER 1000 recorder. The SEER 1000 Apple App assists in the hook-up procedure (e.g. displaying of ECG data and setting of patient demographic data).
getemed Medizin- und Informationstechnik AG
V1.2.1
In Commercial Distribution

  • 04250903201202 ()
2067634-056

  • Electrocardiographic ambulatory recorder
The SEER 1000 PC App is a software product which is an accessory to the SEER 1000 recorder. The SEER 1000 PC App assists in the hook-up procedure (e.g. displaying of ECG data and setting of patient demographic data).
getemed Medizin- und Informationstechnik AG
V1.0SP03
In Commercial Distribution

  • 04250903201196 ()
2067634-055

  • Electrocardiographic ambulatory recorder
No Description
Thought Technology Ltd.
SA4520
In Commercial Distribution

  • 07540191000623 ()


  • Psychophysiological biofeedback system
Babysat System Application.
Owlet Baby Care, Inc.
2.23.0
In Commercial Distribution

  • 00810099090079 ()


  • Multiple vital physiological parameter monitoring system, home-use
SFTWR CSS7200 GRDN MBL IOS V 4.1.0
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000381103 ()


  • Patient health record information system application software
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