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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ALIMED, INC.
910398ZBW
In Commercial Distribution

  • 00733657259018 ()
2970011543

  • Operating table mattress, basic
The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery.
Canary Medical USA LLC
43-5570-002-14
In Commercial Distribution

  • 00860003118313 ()


  • Medical networking interface unit
The ZEISS® Connect App mobile application will be an optional accessory of ZEISS® UNO 3 microscope product. ZEISS® Connect application SW will be available to the end user as an iOS app and user should be able to download and install the same from Apple App store. ZEISS® Connect App will pair wirelessly to the UNO3 variants of microscope and associated peripheral devices (like monitor etc.). This database entry covers UDI for SW version 2.0 and higher. Version 2.0-> UDI - (01)04049539070135(10)200-> Version 3.0-> UDI - (01)04049539070135(10)301 ->Version 4.2-> UDI - (01)04049539070135(10)420
Carl Zeiss Meditec AG
2.0
In Commercial Distribution

  • 04049539070135 ()


  • Multidisciplinary medical image management software
"INFANT DRAW" Disposable Pressure Transducer, Neonatal, 30cc/hr Flow Rate, Arterial Blood Collection System, 6cc Reservoir, For Use with Syringe Pumps, 24" Line
UTAH MEDICAL PRODUCTS, INC.
II - PLUS
In Commercial Distribution

  • H671ABC328NP1 ()
  • H671ABC328NP0 ()

  • Flow Rate - 30 cc/hr
ABC-328NP

  • In-line arterial blood sampling set
Disposable Pressure Transducer System, 3cc/hr Flow Rate with Arterial Blood Collection System, 60/12", Macro Drip Chamber
UTAH MEDICAL PRODUCTS, INC.
PLUS ABC KIT
In Commercial Distribution

  • H671ABC260A1 ()
  • H671ABC260A0 ()

  • Flow Rate - 3 cc/hr
ABC-260A

  • In-line arterial blood sampling set
Disposable Pressure Transducer System, 3cc/hr Flow Rate with Arterial Blood Collection System, 60/12", Micro Drip Chamber, 6cc Reservoir
UTAH MEDICAL PRODUCTS, INC.
PLUS ABC KIT
In Commercial Distribution

  • H671ABC26061 ()
  • H671ABC26060 ()

  • Flow Rate - 3 cc/hr
ABC-260-6

  • In-line arterial blood sampling set
Disposable Pressure Transducer System, 3cc/hr Flow Rate with Arterial Blood Collection System, 60/12", Micro Drip Chamber, 3cc Reservoir
UTAH MEDICAL PRODUCTS, INC.
PLUS ABC KIT
In Commercial Distribution

  • H671ABC2601 ()
  • H671ABC2600 ()

  • Flow Rate - 3 cc/hr
ABC-260

  • In-line arterial blood sampling set
Disposable Pressure Transducer System, 3cc/hr Flow Rate with Arterial Blood Collection System, 48/12", Macro Drip Chamber, 6cc Reservoir
UTAH MEDICAL PRODUCTS, INC.
PLUS ABC KIT
In Commercial Distribution

  • H671ABC248A61 ()
  • H671ABC248A60 ()

  • Flow Rate - 3 cc/hr
ABC-248A-6

  • In-line arterial blood sampling set
Disposable Pressure Transducer System, 3cc/hr Flow Rate with Arterial Blood Collection System, 48/12", Macro Drip Chamber, 3cc Reservoir
UTAH MEDICAL PRODUCTS, INC.
PLUS ABC KIT
In Commercial Distribution

  • H671ABC248A1 ()
  • H671ABC248A0 ()

  • Flow Rate - 3 cc/hr
ABC-248A

  • In-line arterial blood sampling set
Disposable Pressure Transducer System, 3cc/hr Flow Rate with Arterial Blood Collection System, 48/12", Micro Drip Chamber, 6cc Reservoir
UTAH MEDICAL PRODUCTS, INC.
PLUS ABC KIT
In Commercial Distribution

  • H671ABC24861 ()
  • H671ABC24860 ()

  • Flow Rate - 3 cc/hr
ABC-248-6

  • In-line arterial blood sampling set
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