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Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-01-300
Not in Commercial Distribution
- 00817491022370 ()
FG-5501-01-300
- Implantable glucose monitoring system
For the wireless mode version of the subject device, combined with an application installed on a tablet that can be used in a home environment, the content of the SPM01K4 convenience kit is:
1 electrostimulator SPM01M1 configuration;
electrodes;
protective skin, and
1 tablet with the MySPM@Home mobile application (SPM01A2).
NCS LAB SRL
SPM01K4
In Commercial Distribution
- 08051122040971 ()
SPM01K4
- Physical therapy transcutaneous neuromuscular electrical stimulation system
DreamMapper Android APAC Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution
- 00606959051317 ()
1127960
- Self-care monitoring/reporting software
DreamMapper Android EU Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution
- 00606959051300 ()
1128265
- Self-care monitoring/reporting software
DreamMapper Android NA Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution
- 00606959051294 ()
1101479
- Self-care monitoring/reporting software
DreamMapper Android APAC Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution
- 00606959049918 ()
1127960
- Self-care monitoring/reporting software
DreamMapper Android EU Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution
- 00606959049901 ()
1128265
- Self-care monitoring/reporting software
DreamMapper Android NA Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution
- 00606959049895 ()
1101479
- Self-care monitoring/reporting software
DreamMapper Android EU Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution
- 00606959049062 ()
1128265
- Self-care monitoring/reporting software
DreamMapper Android APAC Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution
- 00606959049079 ()
1127960
- Self-care monitoring/reporting software
DreamMapper Android NA Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution
- 00606959049055 ()
1101479
- Self-care monitoring/reporting software
DreamMapper Mobile Application Android (EMEA)
Respironics, Inc.
2.5
In Commercial Distribution
- 00606959042025 ()
1128265
- Self-care monitoring/reporting software
No Description
Dexcom, Inc.
SW14131
In Commercial Distribution
- 00386270004659 ()
- Percutaneous interstitial fluid glucose monitoring system, electrochemical
No Description
Dexcom, Inc.
SW14117
In Commercial Distribution
- 00386270004642 ()
- Percutaneous interstitial fluid glucose monitoring system, electrochemical
No Description
Dexcom, Inc.
SW14116
In Commercial Distribution
- 00386270004635 ()
- Percutaneous interstitial fluid glucose monitoring system, electrochemical
reSET-O® Mobile Application running on Android. reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution
- 10851580008125 ()
- Mental health/function therapeutic software, screen-viewed
reSET-O® Mobile Application running on iOS. reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution
- 10851580008118 ()
- Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on Android. reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12 week (90 days) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to:
- increase abstinence from a patient’s substances of abuse during treatment, and
- increase retention in the outpatient treatment program.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution
- 10851580008095 ()
- Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on iOS. reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12 week (90 days) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to:
- increase abstinence from a patient’s substances of abuse during treatment, and
- increase retention in the outpatient treatment program.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution
- 10851580008088 ()
- Mental health/function therapeutic software, screen-viewed
No Description
NXSTAGE MEDICAL, INC.
NX1379
Not in Commercial Distribution
- M535NX1225NX1379 ()
- Medical equipment clinical data interfacing software
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
267363
In Commercial Distribution
- 03661489673634 ()
- Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
BIOTRONIK SE & Co. KG
493241
In Commercial Distribution
- 04035479188733 ()
493241
- Implantable electrical stimulation device management software
No Description
BIOTRONIK SE & Co. KG
487878
In Commercial Distribution
- 04035479185817 ()
487878
- Implantable electrical stimulation device management software
App for controlling Biomeme Frankin three9 thermocycler when used with the Biomeme Real-Time RT-PCR SARS-CoV-2 Test
Biomeme, Inc.
2.3.5
In Commercial Distribution
- 00810096640130 ()
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
SFTWR MMT-6122 FOTA IOS V1.3.4
MEDTRONIC MINIMED, INC.
MMT-6122
In Commercial Distribution
- 00763000532178 ()
- Patient health record information system application software
SFTWR MMT-6121 FOTA ANDROID V1.3.4
MEDTRONIC MINIMED, INC.
MMT-6121
In Commercial Distribution
- 00763000532161 ()
- Patient health record information system application software
MEGA-AMZ-TAMP-1 - FLO Organic Cotton App Tampons Regular Pack (80 Tampons)
HERE WE FLO LTD
MEGA-AMZ-TAMP-1
In Commercial Distribution
- 05060630101497 ()
- Menstrual tampon, unscented
STRPR 1.2 APP, LINKED BL STREAMER PRO 1.2 NO LOGO
Oticon A/S
139346
In Commercial Distribution
- 05707131268563 ()
- Hearing aid neck induction loop, wireless input
STRPR 1.2 APP, LINKED WH STREAMER PRO 1.2 NO LOGO
Oticon A/S
139342
In Commercial Distribution
- 05707131268549 ()
- Hearing aid neck induction loop, wireless input
Med Aire Assure 5" Air + 3" Foam APP and LAL
Drive Devilbiss Healthcare
14530
In Commercial Distribution
- 00822383536323 ()
- Alternating-pressure bed mattress overlay, reusable
- Alternating-pressure inflator
- Alternating-pressure bed mattress overlay system