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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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SEER 1000 - 04250903201011

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
48 Hour - Korean
In Commercial Distribution

  • 04250903201011 ()
2067634-068

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903200991

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
24 Hour - Korean
In Commercial Distribution

  • 04250903200991 ()
2067634-067

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903200915

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
7 day - UNI
In Commercial Distribution

  • 04250903200915 ()
2067634-060

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903200892

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
48 hour - UNI
In Commercial Distribution

  • 04250903200892 ()
2067634-059

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903200878

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
24 hour - UNI
In Commercial Distribution

  • 04250903200878 ()
2067634-058

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903200748

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
7 day - Korean
Not in Commercial Distribution

  • 04250903200748 ()
2067634-069

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903200731

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
48 hour - Korean
Not in Commercial Distribution

  • 04250903200731 ()
2067634-068

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903200724

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
24 hour - Korean
Not in Commercial Distribution

  • 04250903200724 ()
2067634-067

  • Electrocardiographic ambulatory recorder

N/A - 04961333242023

MANOMETER CABLE
PENTAX OF AMERICA, INC.
7182-2400
In Commercial Distribution

  • 04961333242023 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333242016

MANOMETER CABLE
PENTAX OF AMERICA, INC.
7182-2300
In Commercial Distribution

  • 04961333242016 ()


  • Manometric gastrointestinal motility analysis system

n/a - 04961333231614

REMOVABLE HARD DRIVES FOR 7245C
PENTAX OF AMERICA, INC.
7202B
In Commercial Distribution

  • 04961333231614 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333231089

SYNC MODULE FOR FULL SYSTEM
PENTAX OF AMERICA, INC.
7127
Not in Commercial Distribution

  • 04961333231089 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333231072

TONGUE HARDWARE W/25 ARRAYS
PENTAX OF AMERICA, INC.
7124
In Commercial Distribution

  • 04961333231072 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333230464

Tongue Arrays
PENTAX OF AMERICA, INC.
7179-0040
In Commercial Distribution

  • 04961333230464 ()
  • 34961333230465 ()


  • Manometric gastrointestinal motility analysis system

n/a - 04961333230457

Tongue Arrays
PENTAX OF AMERICA, INC.
7179-0035
In Commercial Distribution

  • 04961333230457 ()
  • 34961333230458 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333230433

Electrodes
PENTAX OF AMERICA, INC.
7179-0025
In Commercial Distribution

  • 04961333230433 ()
  • 14961333230439 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333230426

Electrodes
PENTAX OF AMERICA, INC.
7179-0020
In Commercial Distribution

  • 04961333230426 ()
  • 14961333230422 ()


  • Manometric gastrointestinal motility analysis system

n/a - 04961333231386

DIGITAL SWALLOWING CABLE
PENTAX OF AMERICA, INC.
7184-5900
In Commercial Distribution

  • 04961333231386 ()


  • Manometric gastrointestinal motility analysis system

n/a - 04961333231362

THREE BULB ARRAY
PENTAX OF AMERICA, INC.
7181-9900
In Commercial Distribution

  • 04961333231362 ()


  • Manometric gastrointestinal motility analysis system

n/a - 04961333231355

TWO BULB ARRAY
PENTAX OF AMERICA, INC.
7181-9800
In Commercial Distribution

  • 04961333231355 ()


  • Manometric gastrointestinal motility analysis system

n/a - 04961333231348

EMG CABLE,6' (1250-0334)
PENTAX OF AMERICA, INC.
7180-2102
In Commercial Distribution

  • 04961333231348 ()

  • Length: 6.0 Feet


  • Manometric gastrointestinal motility analysis system

n/a - 04961333231331

EMG CABLE,6' (1250-0335)
PENTAX OF AMERICA, INC.
7180-2101
In Commercial Distribution

  • 04961333231331 ()

  • Length: 6.0 Feet


  • Manometric gastrointestinal motility analysis system

N/A - 04961333231317

SYNC MODULE FOR PAL 230V
PENTAX OF AMERICA, INC.
7127E
Not in Commercial Distribution

  • 04961333231317 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333231300

SWALLOWING UPGRADE
PENTAX OF AMERICA, INC.
7120B-2
Not in Commercial Distribution

  • 04961333231300 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333231188

ANALOG-DIGITAL CONVERT DFG/SV1
PENTAX OF AMERICA, INC.
1111-1582
In Commercial Distribution

  • 04961333231188 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333231171

MONITOR, ACER V196L 19" LCD
PENTAX OF AMERICA, INC.
1111-1420
In Commercial Distribution

  • 04961333231171 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333230495

Tongue Arrays
PENTAX OF AMERICA, INC.
7183-4500
In Commercial Distribution

  • 04961333230495 ()
  • 34961333230496 ()


  • Manometric gastrointestinal motility analysis system

n/a - 04961333230440

Nasal Cannulas
PENTAX OF AMERICA, INC.
7179-0030
In Commercial Distribution

  • 04961333230440 ()
  • 14961333230446 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333229956

Laryngeal Microphone
PENTAX OF AMERICA, INC.
7126
In Commercial Distribution

  • 04961333229956 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333229949

Nasal Cannulas
PENTAX OF AMERICA, INC.
7125
In Commercial Distribution

  • 04961333229949 ()
  • 14961333229945 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333229932

Manometry Sensors (Gaeltec)
PENTAX OF AMERICA, INC.
7123
In Commercial Distribution

  • 04961333229932 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333229925

EMG Transducers (two channel)
PENTAX OF AMERICA, INC.
7122
In Commercial Distribution

  • 04961333229925 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482569

ESO Catheter, RFG
Given Imaging, Inc.
RFG-1286
In Commercial Distribution

  • 04260167482569 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482521

ESO Catheter, SD Small
Given Imaging, Inc.
RFG-3886
In Commercial Distribution

  • 04260167482521 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482507

ESO Z Catheter
Given Imaging, Inc.
RFG-3890
In Commercial Distribution

  • 04260167482507 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482484

ESO Catheter
Given Imaging, Inc.
1286
In Commercial Distribution

  • 04260167482484 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482477

AR Catheter, Regular
Given Imaging, Inc.
2192
In Commercial Distribution

  • 04260167482477 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482460

AR Catheter, Small
Given Imaging, Inc.
2195
In Commercial Distribution

  • 04260167482460 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482453

ESO Catheter, SD Small
Given Imaging, Inc.
3886
In Commercial Distribution

  • 04260167482453 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482446

ESO Z Catheter
Given Imaging, Inc.
3890
In Commercial Distribution

  • 04260167482446 ()


  • Manometric gastrointestinal motility analysis system
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