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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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GL GoodLife Blood Glucose Test Strip AC (50ct in foil) - 00389154000075

GoodLife AC Blood Glucose Test Strips
HMD BIOMEDICAL INC.
AC11-Foil
Not in Commercial Distribution

  • 00389154000075 ()
  • 00389154000556 ()
3K-01-16003C

  • Home-use/point-of-care blood glucose/blood pressure monitoring system

BA KIT,WE,P800,IN,1',BE,S37,INL,6' - 00840828134101

BA 1/2 KIT,WE,P37,INL,6',NO DP
CURBELL MEDICAL PRODUCTS, INC.
BCC-3060-C01-A06-001
In Commercial Distribution

  • 00840828134101 ()
15386

  • Electrical-only medical device connection cable, reusable

8.5 in (22 cm) 3 Double T-site IV Extension Set - 00634624957114

No Description
QUEST MEDICAL INC
95711
In Commercial Distribution

  • 20634624957118 ()
  • 00634624957114 ()
95711

  • Intravenous administration tubing extension set

MPS® Extension Tubing, 6 ft. x 1/8 in. - 00634624701144

No Description
QUEST MEDICAL INC
7001104
In Commercial Distribution

  • 20634624701148 ()
  • 00634624701144 ()
7001104

  • Cardioplegia solution administration kit

MPS® Extension Tubing, 6 ft. x 3/16 in. - 00634624701137

No Description
QUEST MEDICAL INC
7001103
In Commercial Distribution

  • 20634624701131 ()
  • 00634624701137 ()
7001103

  • Cardioplegia solution administration kit

Rondex CPR Pocket Rescue Mask (Made in USA) model #9120 - 06343760091203

The Rondex CPR Pocket Rescue Mask, Model #9120, is for emergency mouth-to-mask ventilation on a non-breathing adult or child. There is a silicone valve inside the valve housing to help isolate the patient's breath from the rescuer. The mask has a unique design (Design Registered) that even allows rescuers with small hands or rescuers with wet hands a more comfortable means to hold the mask. The mask can be folded down and stored in the plastic clamshell case along with the valve. Made In USA
RONDEX PRODUCTS, INCORPORATED
9120 (packaged in a plastic clamshell case)
Not in Commercial Distribution

  • 06343760091203 ()
9120

  • Cardiopulmonary resuscitation mask, single-use

Welldoc App for Diabetes in Pregnancy and Insulin Pump Users - B553202058OTC0

The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump. The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates electronic reports intended for a healthcare provider. The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies. The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
v2.X
Not in Commercial Distribution

  • B553202058OTC0 ()


  • Self-care monitoring/reporting software

4.0 mm x 13mm Simpler Push in HA Dental Implants - D780S50070

Hydroxylapatite (HA) coated push in dental implant 4.0 mm diameter x 13mm length
Simpler Implant Solutions Inc
S5007
In Commercial Distribution

  • D780S50070 ()

  • 4.0mm diameter x 7 millimerts length
S5007

  • Screw endosteal dental implant, two-piece

4.0mm x 8 mm Simpler Push in HA Dental Implants - D780S50050

Hydroxylapatite (HA) coated push in dental implant 4.0mm x 8mm length
Simpler Implant Solutions Inc
S5005
In Commercial Distribution

  • D780S50050 ()

  • 4.0 millimeters diameter x 08 millimeters length
S5005

  • Screw endosteal dental implant, two-piece

3.25 mm x 10mm Simpler Push In HA Dental Implants - D780S50020

Hydroxylapatite (HA) coated push in dental implant 3.25 mm diameter x 10mm length
Simpler Implant Solutions Inc
S5002
In Commercial Distribution

  • D780S50020 ()

  • 3.25 millimeters diameter X 10 millimeter length
S5002

  • Screw endosteal dental implant, two-piece
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