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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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Redicare - B70901130070

1 Triangular Bandage 40x40x56 inch with Clips 1/box
REDICARE LLC
Triangular Bandage
In Commercial Distribution

  • B70901130071 ()
  • B70901130070 ()


  • Suspension arm sling

Redicare - B70901070040

1 Instant Ice Pack Compress Large 5" x 8"
REDICARE LLC
Instant Ice Pack 5" x 8"
In Commercial Distribution

  • B70901070041 ()
  • B70901070040 ()

  • Width: 5 Inch
  • Length: 8 Inch
0107004

  • Hot/cold therapy pack, single-use

Redicare - B70901040100

1 Cohesive Non-Adhesive Self Adherent Flex Bandage Wrap Non-Sterile Bandage Roll 3" x 5yds
REDICARE LLC
Cohesive Flex Bandage
In Commercial Distribution

  • B70901040101 ()
  • B70901040100 ()
0104010

  • Non-adhesive device retention bandage

IMACTIS® - B681J000970

Cart for the IMACTIS® CT-NAVIGATION system
IMACTIS
J00097
In Commercial Distribution

  • B681J000970 ()
  • B681J000971 ()
MA-J00097

  • Utility trolley

Monarch Advanced Imaging Accessory Kit - B634MON0007090

Window Field Generator, Connection Cable, Mounting System
AURIS HEALTH, INC.
MON-000709
In Commercial Distribution

  • B634MON0007091 ()
  • B634MON0007090 ()
MON-000709

  • Robotic surgical arm system

Navigation Patient Patches - B634MBR0000160

Navigation Patient Patches (Quantity of 60)
AURIS HEALTH, INC.
MBR-000016
In Commercial Distribution

  • B634MBR0000161 ()
  • B634MBR0000160 ()
MBR-000016

  • Hypoallergenic skin adhesive tape

DCTclock - B626100930

DCTclock Practice Test Form - clinical
Linus Health, Inc.
10093
In Commercial Distribution

  • B626100931 ()
  • B626100930 ()
10093

  • Drawing-test cognitive function analysis device

DCTclock - B626100390

DCTclock Practice Test Form - Research
Linus Health, Inc.
10039
In Commercial Distribution

  • B626100391 ()
  • B626100390 ()
10039

  • Drawing-test cognitive function analysis device

Peerbridge Cor System - B608CORXT0

CORXT The Peerbridge Cor™ System is a family of products comprised of two models, the Peerbridge Cor™ XT ("Cor XT") and the Peerbridge Cor™ Event ("Cor Event"). The system is an ambulatory wearable ECG monitoring system designed to record and provide patient's electrocardiogram (ECG) data to the clinician. The Peerbridge System consists of five components: (1) Wearable ECG Sensor with Bluetooth technology, (2) Adhesive Electrode (3) dedicated Handheld Transmitter Device, (4) Data Upload Fixture and Software that allow ECG data to be uploaded from the Wearable ECG Sensor to a PC and then to the Backend, and (5) Cloud-based Backend Data Management Module. The Wearable ECG sensor attaches to the patient's chest and records the patient's ECG continuously. This device can collect two (2) channels and 3-leads of ECG data continuously for up to seven (7) days. In addition, patients can report symptomatic events by pressing the Event Button on the Wearable ECG Sensor or by using the mobile application on the Handheld Transmitter when a symptom is experienced. The device generates ECG reports to be displayed on the clinician's interface. The Peerbridge System Cor XT is configured for the following: - 24 hours of Holter monitoring and - Up to 7 days of Holter Monitoring
PEERBRIDGE HEALTH, INC.
CORXT
In Commercial Distribution

  • B608CORXT1 ()
  • B608CORXT0 ()
CORXT

  • Wearable multiple physiological parameter recorder, reusable

Peerbridge Cor System - B608COREVENT0

COREVENT The Peerbridge Cor™ System is a family of products comprised of two models, the Peerbridge Cor™ XT ("Cor XT") and the Peerbridge Cor™ Event ("Cor Event"). The system is an ambulatory wearable ECG monitoring system designed to record and provide patient's electrocardiogram (ECG) data to the clinician. The Peerbridge System consists of five components: (1) Wearable ECG Sensor with Bluetooth technology, (2) Adhesive Electrode (3) dedicated Handheld Transmitter Device, (4) Data Upload Fixture and Software that allow ECG data to be uploaded from the Wearable ECG Sensor to a PC and then to the Backend, and (5) Cloud-based Backend Data Management Module. The Wearable ECG sensor attaches to the patient's chest and records the patient's ECG continuously. This device can collect two (2) channels and 3-leads of ECG data continuously for up to seven (7) days. In addition, patients can report symptomatic events by pressing the Event Button on the Wearable ECG Sensor or by using the mobile application on the Handheld Transmitter when a symptom is experienced. The device generates ECG reports to be displayed on the clinician's interface. The Peerbridge System Cor Event is configured for the following: - 24 hours of Holter monitoring - Patient Activated Event with Surveillance
PEERBRIDGE HEALTH, INC.
COREVENT
In Commercial Distribution

  • B608COREVENT0 ()
  • B608COREVENT1 ()
COREVENT

  • Wearable multiple physiological parameter recorder, reusable
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