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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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AincA® - B005LF380500

Mask, Laryngeal Airway, Ultra EX, Size5.0 (11.0mmID), 15mmM, 40xReusable, Silicone
ANESTHESIA ASSOCIATES, INC.
LF-380-50
In Commercial Distribution

  • B005LF380500 ()

  • 5
LF-380-50

  • Oropharyngeal airway, single-use

AincA® - B005LF17250

Mask, Face, Ambu Type Clear, Inflatable Cuff Seal, 22mmF, Size 5 Adult, Silicone/PC (see 00-333-4)
ANESTHESIA ASSOCIATES, INC.
LF-172-5
In Commercial Distribution

  • B005LF17250 ()

  • 5
LF-172-5

  • Anaesthesia face mask, reusable

AincA® - B005LF13650

Mask, Face, Clear Silicone, Flap Seal, 22mmF w/Hook Ring, Size 5 Large Adult, Silicone/Polycarbonate
ANESTHESIA ASSOCIATES, INC.
LF-136-5
In Commercial Distribution

  • B005LF13650 ()

  • 5
LF-136-5

  • Anaesthesia face mask, reusable

AincA® - B005GL36550

Blade, Laryngoscope, GreenLine F/O, Macintosh, English Profile, Size 5 Large Adult (184mm)
ANESTHESIA ASSOCIATES, INC.
GL-365-5
In Commercial Distribution

  • B005GL36550 ()

  • 5
GL-365-5

  • Rigid intubation laryngoscope, reusable

AincA® - B005E13550

Mask, BOC Type, Inflatable Cuff Seal, 22mmF, Size 5 Large, w/Hook Ring, Conductive Neoprene w/ Latex
ANESTHESIA ASSOCIATES, INC.
E-135-5
In Commercial Distribution

  • B005E13550 ()

  • 5
E-135-5

  • Anaesthesia face mask, reusable

UbiqVue Multiparameter - B353UB25501

2A Wearable Biosensor
Lifesignals, Inc.
UB2550
In Commercial Distribution

  • B353UB25502 ()
  • B353UB25501 ()
  • B353UB25503 ()


  • Wearable multiple physiological parameter recorder, single-use

UbiqVue Holter - B353UB22511

2AYe Wearable Biosensor
Lifesignals, Inc.
UB2251
In Commercial Distribution

  • B353UB22512 ()
  • B353UB22511 ()
  • B353UB22513 ()


  • Electrocardiographic ambulatory recorder

UbiqVue Multiparameter - B353UB15501

1AX Wearable Biosensor
Lifesignals, Inc.
UB1550
In Commercial Distribution

  • B353UB15501 ()
  • B353UB15502 ()
  • B353UB15503 ()


  • Wearable multiple physiological parameter recorder, single-use

MonitorMe - B353MM12501

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
MM1250
Not in Commercial Distribution

  • B353MM12501 ()
  • B353MM12502 ()
  • B353MM12503 ()


  • Electrocardiography telemetric monitoring system

LifeSignals - B353LP12501

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1250
Not in Commercial Distribution

  • B353LP12502 ()
  • B353LP12501 ()
  • B353LP12503 ()


  • Electrocardiographic ambulatory recorder
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