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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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The Calypso Pro Electrical Breast Pump is intended to be used by lactating women to express and collect milk from theis breast. It can be used as a single and as double pump. The unit is intended for indoor use only and is intended for multiple users.
Ardo medical AG
63.00.336
In Commercial Distribution

  • 00814079021992 ()
  • 00814079022029 ()
63.00.336

  • Breast pump, electric
The Calypso breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users. The package also contains an adapter for manual pumping as well as spare parts for the pumpset.
Ardo medical AG
63.00.330
In Commercial Distribution

  • 00814079021909 ()
63.00.330

  • Breast pump, electric
The Calypso breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users. The package also contains an adapter for manual pumping as well as spare parts for the pumpset.
Ardo medical AG
63.00.320
In Commercial Distribution

  • 00814079021800 ()
63.00.320

  • Breast pump, electric
The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express and collect milk from their breast. The Pumpset can be used both as a single pumpset and as a double pumpset and is intented for single users only.
Ardo medical AG
63.00.125
In Commercial Distribution

  • 00814079021657 ()
  • 00814079021640 ()
63.00.125

  • Breast pump support kit, single-use
The One Mum Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express and collect milk from their breast. The One Mum Pumpset can be used both as a single pumpset and as a double pumpset and is intended for single users only.
Ardo medical AG
63.00.114
In Commercial Distribution

  • 00814079021541 ()
  • 00814079021534 ()
63.00.114

  • Breast pump support kit, single-use
The ARDO Carum powered breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for multiple users.
Ardo medical AG
61.00.74
In Commercial Distribution

  • 00814079021053 ()
61.00.74

  • Breast pump, electric
The ARDO Carum powered breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for multiple users.
Ardo medical AG
63.00.77
In Commercial Distribution

  • 00814079021022 ()
63.00.77

  • Breast pump, electric
The Calypso breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users.
Ardo medical AG
63.00.287
In Commercial Distribution

  • 00814079020964 ()
63.00.287

  • Breast pump, electric
  • Breast pump support kit, reusable
The Calypso Pro breastpump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for multiple users.
Ardo medical AG
63.00.286
In Commercial Distribution

  • 00814079020919 ()
  • 00814079020902 ()
63.00.286

  • Breast pump, electric
The Calypso breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users.
Ardo medical AG
63.00.282
In Commercial Distribution

  • 00814079020858 ()
  • 00814079020841 ()
63.00.282

  • Breast pump, electric
The Calypso Pro breastpump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for multiple users.
Ardo medical AG
63.00.281
In Commercial Distribution

  • 00814079020810 ()
63.00.281

  • Breast pump, electric
The ARDO Carum powered breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for multiple users.
Ardo medical AG
63.00.73
In Commercial Distribution

  • 00814079020605 ()
63.00.73

  • Breast pump, electric
The Calypso breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users.
Ardo medical AG
63.00.240
In Commercial Distribution

  • 00814079020063 ()
63.00.240

  • Breast pump, electric
  • Breast pump support kit, reusable
The Calypso breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users.
Ardo medical AG
63.00.243
In Commercial Distribution

  • 00814079020049 ()
  • 00814079020032 ()
63.00.243

  • Breast pump support kit, reusable
  • Breast pump, electric
The Calypso breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users.
Ardo medical AG
63.00.242
In Commercial Distribution

  • 00814079020001 ()
  • 00814079020018 ()
63.00.242

  • Breast pump, electric
  • Breast pump support kit, reusable
CUBEScan BioCon-1100 (Bladder volume measurement system) is a safe, easy to use, non-invasive system for measuring bladder volume (residual volume). CUBEScan BioCon-1100 is a B-mode ultrasound device, which consists of a probe that sends and receives ultrasonic waves, and a console that processes ultrasonic signals and converts them into the desired data. The 3D-mechanical sector transducer take the bladder in 12 sections and calculate the volume of the bladder based on the images which appear on the LCD screen. In addition, the pre-scan function allows users to easily locate the location of the bladder before scanning, making measurement easier. Measurement results can be transferred to a computer, and data can be managed using CubePro-1100. CubePro-1100 has functions such as printing measurement results, storing data and so on.
Mcube Technology Co., Ltd.
BioCon-1100
In Commercial Distribution

  • 08809458500115 ()


  • Bladder volume ultrasound imaging system
The BioCon-750 is a portable ultrasound system for measuring the urine volume in a patient. BioCon-750 transmits ultrasound signals to the abdomen of a patient and receives the echoed signals. Using the echoed signals the system detects the bladder outlines and calculates the volume in bladder outlines. BioCon-750 has a Pre-Scan function, which shows the ultrasound images for a horizontal plane consisted of the echoed signals. The Pre-Scan function helps a user locate the bladder easily and get more accurate results. A user can print the results using a built-in thermal printer after measurements right away. Also using the optional CubeScan PC software you can upload the saved data in a device's flash ROM to a computer for reviewing the scan results.
Mcube Technology Co., Ltd.
BioCon-750
In Commercial Distribution

  • 08809458500108 ()


  • Bladder volume ultrasound imaging system
CUBEScan BioCon-900S is a safe and easy, non-invasive system to measure the bladder volume. The device consists of a probe and various components. The probe is a B-mode instrument, which is hand-held, wireless and battery-operated. A 3D-mechanical sector transducer provides cross–sectional images of the bladder from up to 12 scan planes which users can check through the screen and bladder volume is calculated based upon those images. In addition, the Pre-scan function allows users to easily locate the bladder before scanning, making measurement easier. CUBEScan BioCon-900S consists of a probe and CUBEscan Charger or a probe and CUBEScan Docking Station, with an optional mobile cart and a barcode module.
Mcube Technology Co., Ltd.
BioCon-900S
In Commercial Distribution

  • 08809458500085 ()


  • Bladder volume ultrasound imaging system
The BioCon-700 is a portable ultrasound system for measuring the urine volume in a patient. BioCon-700 transmits ultrasound signals to the abdomen of a patient and receives the echoed signals. Using the echoed signals the system detects the bladder outlines and calculates the volume in bladder outlines. BioCon-700 has a Pre-Scan function, which shows the ultrasound images for a horizontal plane consisted of the echoed signals. The Pre-Scan function helps a user locate the bladder easily and get more accurate results. A user can print the results using a built-in thermal printer after measurements right away. Also using the optional CubeScanPC software you can upload the saved data in a device's flash ROM to a computer for reviewing the scan results.
Mcube Technology Co., Ltd.
BioCon-700
In Commercial Distribution

  • 08809458500016 ()


  • Bladder volume ultrasound imaging system
CUBEScan BioCon-900 (bladder volume measurement system) is a safe and easy, noninvasive system to measure the bladder volume. CUBEScan BioCon-900 is a B-mode instrument, hand-held, wireless and battery-operated. A 3D-mechnical sector transducer provides cross-sectional images of the bladder from up to 12 scan planes and bladder volume is calculated based upon those images and displays 12 scan planes on a screen. Furthermore, a live image of the bladder during Pre-scan makes it easier to detect the bladder before scanning. Measurements are transmitted to a personal computer running CubePro software via a wireless connection. CubePro allows the user to input the patient information, print measurements, export to pdf or jpg, archive data, and review data.
Mcube Technology Co., Ltd.
BioCon-900
In Commercial Distribution

  • 08809458500009 ()


  • Bladder volume ultrasound imaging system
Main Unit;
CNSystems Medizintechnik GmbH
V1.5
In Commercial Distribution

  • 09120073932266 ()
21-FHCN-15544

  • Patient monitoring system module, blood pressure, noninvasive
Main Unit; including Quick Guide
CNSystems Medizintechnik GmbH
V1.5
In Commercial Distribution

  • 09120073932242 ()
21-FHCN-15544

  • Patient monitoring system module, blood pressure, noninvasive
Unit; Fingersensor for Task Force® Monitor (large); Luer
CNSystems Medizintechnik GmbH
G2.3
In Commercial Distribution

  • 09120073932211 ()
FVMA0053

  • General-purpose multi-parameter bedside monitor
Unit; Fingersensor for Task Force® Monitor (small); Rectus
CNSystems Medizintechnik GmbH
G2.2
In Commercial Distribution

  • 09120073932143 ()
00054

  • General-purpose multi-parameter bedside monitor
Unit;2.5m, ECG cable for Task Force® Monitor without protection against defibrillation, "double nose" connector
CNSystems Medizintechnik GmbH
A
In Commercial Distribution

  • 09120073932112 ()
00021

  • General-purpose multi-parameter bedside monitor
Unit; Fingersensor for Task Force® Monitor (medium); Luer
CNSystems Medizintechnik GmbH
G2.2
In Commercial Distribution

  • 09120073932068 ()
FVMA0052

  • General-purpose multi-parameter bedside monitor
Unit; Fingersensor for Task Force® Monitor (small); Rectus
CNSystems Medizintechnik GmbH
G2.2
Not in Commercial Distribution

  • 09120073932044 ()
00054

  • General-purpose multi-parameter bedside monitor
Unit; Fingersensor for Task Force® Monitor (medium); Rectus
CNSystems Medizintechnik GmbH
G2.2
In Commercial Distribution

  • 09120073932037 ()
00055

  • General-purpose multi-parameter bedside monitor
Unit; Fingersensor for Task Force® Monitor (large); Rectus
CNSystems Medizintechnik GmbH
G2.2
In Commercial Distribution

  • 09120073932020 ()
00056

  • General-purpose multi-parameter bedside monitor
Set of 4ECG electrodes, 3 ICG electrodes and one grounding pad
CNSystems Medizintechnik GmbH
V1.0
In Commercial Distribution

  • 09120073931962 ()
  • 09120073931955 ()
  • 09120073931948 ()
1616

  • Analytical non-scalp cutaneous electrode
Task Force® Monitor software incl. customer CD (multilingual)
CNSystems Medizintechnik GmbH
V2.3
In Commercial Distribution

  • 09120073931931 ()
FHCS3043

  • General-purpose multi-parameter bedside monitor
Main Unit;
CNSystems Medizintechnik GmbH
V2
Not in Commercial Distribution

  • 09120073931924 ()
FHTF3141

  • General-purpose multi-parameter bedside monitor
Unit;2.5m, ICG cable for Task Force® Monitor without protection against defibrillation, "double nose" connector
CNSystems Medizintechnik GmbH
X
In Commercial Distribution

  • 09120073931917 ()
00031

  • General-purpose multi-parameter bedside monitor
Unit;2.5m, ICG cable for Task Force® Monitor with protection against defibrillation, "double nose" connector
CNSystems Medizintechnik GmbH
A
In Commercial Distribution

  • 09120073931900 ()
00033

  • General-purpose multi-parameter bedside monitor
Unit; for Vascular Unloading device (arm fixation cuff contBP module)
CNSystems Medizintechnik GmbH
V1.0
In Commercial Distribution

  • 09120073931894 ()
00058

  • General-purpose multi-parameter bedside monitor
Unit; Fingersensor for Task Force® Monitor (small); Luer
CNSystems Medizintechnik GmbH
G2.1
Not in Commercial Distribution

  • 09120073931887 ()
FVMA0051

  • General-purpose multi-parameter bedside monitor
Unit; adapter between CNAP® controller and CNAP® forearm fixing cuff
CNSystems Medizintechnik GmbH
V1.5
In Commercial Distribution

  • 09120073931825 ()
21-FEZU-15401

  • Patient monitoring system module, blood pressure, noninvasive
Unit; External inputs cable for Task Force® Monitor; 2,5m
CNSystems Medizintechnik GmbH
X
Not in Commercial Distribution

  • 09120073931818 ()
HEKA3141

  • General-purpose multi-parameter bedside monitor
Unit;2.5m, ECG cable for Task Force® Monitor without protection against defibrillation, "double nose" connector
CNSystems Medizintechnik GmbH
X
In Commercial Distribution

  • 09120073931801 ()
00021

  • General-purpose multi-parameter bedside monitor
Unit;2.5m, ECG cable for Task Force® Monitor with protection against defibrillation, "double nose" connector
CNSystems Medizintechnik GmbH
A
In Commercial Distribution

  • 09120073931795 ()
00023

  • General-purpose multi-parameter bedside monitor
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