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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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Meridian Medical - 00815067040162

APP SYSTEM AIR ADJUSTABLE
COMPASS HEALTH BRANDS CORP.
1003
In Commercial Distribution

  • 30815067040163 ()
  • 00815067040162 ()


  • Alternating-pressure bed mattress overlay system

Omnipod 5 Controller APP - 10385083000565

Omnipod 5 Controller APP
Insulet Corporation
M009-3P-AP
In Commercial Distribution

  • 10385083000565 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

Omnipod 5 Controller APP - 10385083000336

Omnipod 5 Controller APP
Insulet Corporation
M009-S-AP
In Commercial Distribution

  • 10385083000336 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

PRC-Saltillo - 00816486021367

TC Discover App UDID
PRENTKE ROMICH COMPANY
Discover App
In Commercial Distribution

  • 00816486021367 ()
19285-9

  • Voice synthesizer/digitizer

Biim Android App, P2.0 - 07090045490334

Biim Android App, P2.0
Biim Ultrasound AS
P001425
In Commercial Distribution

  • 07090045490334 ()
P001425

  • Hand-held ultrasound imaging system, body-surface
  • Extracorporeal ultrasound imaging transducer, hand-held

Biim Android App, P1.3.2 - 07090045490310

Biim Android App, P1.3.2
Biim Ultrasound AS
P001418
In Commercial Distribution

  • 07090045490310 ()
P001418

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface

Biim Android App, P1.3.1 - 07090045490235

Biim Android App, P1.3.1
Biim Ultrasound AS
P001403
In Commercial Distribution

  • 07090045490235 ()
P001403

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface

Biim Android App, P1.3 - 07090045490198

Biim Android App, P1.3
Biim Ultrasound AS
P001228
In Commercial Distribution

  • 07090045490198 ()
P001228

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface

Biim Android App, P1.2 - 07090045490150

Biim Android App, P1.2
Biim Ultrasound AS
P001158
In Commercial Distribution

  • 07090045490150 ()
P001158

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface

Biim Android App, P1.1 - 07090045490020

Biim Android App, P1.1
Biim Ultrasound AS
P001118
In Commercial Distribution

  • 07090045490020 ()
P001118

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface

Argon Adult EPD Grande Femoral Drape - 00886333212477

Argon Adult EPD Grande Femoral Drape 86" x 135" w/Full Transparent Windows
ARGON MEDICAL DEVICES, INC.
396122
Not in Commercial Distribution

  • 20886333212471 ()
  • 00886333212477 ()

  • 86" x 135"
396122

  • Patient surgical drape, single-use

Argon Basic EPD Grande Femoral Drape - 00886333212460

Argon Basic EPD Grande Femoral Drape 86" x 135" w/Full Transparent Windows
ARGON MEDICAL DEVICES, INC.
396120
Not in Commercial Distribution

  • 20886333212464 ()
  • 00886333212460 ()

  • 86" x 135"
396120

  • Patient surgical drape, single-use

Basic Adult EPD Femoral Angio Drape - 00886333212453

Basic Adult EPD Femoral Angio Drape 75" x 125" w/Full Transparent Windows
ARGON MEDICAL DEVICES, INC.
396112
Not in Commercial Distribution

  • 20886333212457 ()
  • 00886333212453 ()

  • 75" x 125"
396112

  • Patient surgical drape, single-use

Basic Adult EPD Femoral Angio Drape - 00886333212446

Basic Adult EPD Femoral Angio Drape 75" x 125" w/Full Transparent Windows
ARGON MEDICAL DEVICES, INC.
396111
Not in Commercial Distribution

  • 20886333212440 ()
  • 00886333212446 ()

  • 75" x 125"
396111

  • Patient surgical drape, single-use

Basic Adult EPD Femoral Angio Drape - 00886333212439

Basic Adult EPD Femoral Angio Drape 75" x 125" w/Full Transparent Windows
ARGON MEDICAL DEVICES, INC.
396110
In Commercial Distribution

  • 20886333212433 ()
  • 00886333212439 ()

  • 75" x 125"
396110

  • Angiographic drape

Aadva™ - J0229405021

Aadva™ IOS 100: IOS cart, IOS Handpiece (via USB connection), CPU (onboard computer), G.U.I. touchscreen, holder inserts bags of 10, plug, IFUs (includes: Quick Start Guide & Owners manual).
Gc America Inc.
940502
In Commercial Distribution

  • J0229405021 ()
940502

  • Dental milling system, CAD/CAM, laboratory

NewTom - 08033837932970

The device is an optical impression system. It is used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer-aided design (CAD) and computer-aided manufacturing (CAM) of dental restorative prosthetic devices.
CEFLA SOCIETA' COOPERATIVA
NewTom IOS
In Commercial Distribution

  • 08033837932970 ()
70960000

  • Intraoral optical scanning system
  • Dental milling system, CAD/CAM, chairside

Lilly Together - 00300021107550

Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices.
ELI LILLY AND COMPANY
MA7723 IOS
In Commercial Distribution

  • 00300021107550 ()
MA7723001AM

  • Medication reminder application software

Transducer C9-4ec - 00884838123762

Transducer C9-4ec as part of Lumify 5.1 iOS
Philips Ultrasound LLC
300013145921
In Commercial Distribution

  • 00884838123762 ()


  • Rectal/vaginal ultrasound imaging transducer

Sleep Apnea Notification Feature (SANF) - 00195949116209

Sleep Apnea Notification Feature iOS (version 1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949116209 ()


  • Self-care monitoring/reporting software
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