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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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Ambu White Sensor 0315M Electrod with solid gel and polymer backing and tab connector. Radiolucent and MR Conditional. Packaging: 100 pouch/500 inner box/ 5000 carton
Ambu A/S
0315M
Not in Commercial Distribution

  • 05060038513533 ()
  • 05060038511072 ()
  • 05060038514448 ()
  • 05707480129140 ()
0315M

  • Electrocardiographic electrode, single-use
Ambu White Sensor 0215M Electrod with solid gel and polymer backing and tab connector. Radiolucent and MR Conditional. Packaging: 100 pouch/500 inner box/ 5000 carton
Ambu A/S
0215M
Not in Commercial Distribution

  • 05060038513687 ()
  • 05060038511133 ()
  • 05060038514424 ()
  • 05707480129133 ()
0215M

  • Electrocardiographic electrode, single-use
Ambu White Sensor 0615M Electrod with solid gel and polymer backing and center tab connector. Radiolucent and MR Conditional. Packaging: 100 pouch/ 500 inner box/ 5000 carton
Ambu A/S
0615M
Not in Commercial Distribution

  • 05060038514042 ()
  • 05060038514035 ()
  • 05060038514028 ()
  • 05707480129409 ()
0615M

  • Electrocardiographic electrode, single-use
Ambu White Sensor 0715M Electrod with solid gel and polymer backing and tab connector. Radiolucent and MR Conditional. Packaging: 100 pouch/ 500 inner box/ 5000 carton
Ambu A/S
0715M
Not in Commercial Distribution

  • 05060038513649 ()
  • 05060038511119 ()
  • 05060038513632 ()
  • 05707480129171 ()
0715M

  • Electrocardiographic electrode, single-use
Ambu White Sensor 4570M Electrode with wet gel and foam backing Center snap and PVC free. For short-term monitoring pediatric. Packing: 30 pouch/300 inner box/ 3000 carton
Ambu A/S
4570M
Not in Commercial Distribution

  • 05060038510563 ()
  • 05060038513120 ()
  • 05060038513137 ()
  • 05707480129331 ()
4570M

  • Electrocardiographic electrode, single-use
Ambu White Sensor 4560M Electrod with wet gel and foam backing. With center snap and PVC free. Packaging: 60 pouch/300 inner box/ 3000 carton
Ambu A/S
4560M
Not in Commercial Distribution

  • 05060038513069 ()
  • 05060038510679 ()
  • 05060038512994 ()
  • 05707480129324 ()
4560M

  • Electrocardiographic electrode, single-use
Ambu White Sensor 4535M Electrode with wet gel and foam backing. Center snap and PVC free For short-term monitoring Packing: 60 pouch/300 inner box/ 3000 carton
Ambu A/S
4535M
Not in Commercial Distribution

  • 05060038512864 ()
  • 05707480129393 ()
  • 05060038512857 ()
  • 05060038510549 ()
4535M

  • Electrocardiographic electrode, single-use
Ambu White Sensor 4500M-H Electrode with wet gel and foam backing Center snap and PVC free. For short-term monitoring Packing: 60 pouch/300 inner box/ 3000 carton
Ambu A/S
4500M-H
Not in Commercial Distribution

  • 05060038512550 ()
  • 05060038512796 ()
  • 05060038510525 ()
  • 05707480129300 ()
4500M-H

  • Electrocardiographic electrode, single-use
Ambu White Sensor 4500M Electrode with wet gel and foam backing Center snap and PVC free. For short-term monitoring Packing: 30 pouch/300 inner box/ 3000 carton
Ambu A/S
4500M
Not in Commercial Distribution

  • 05060038510488 ()
  • 05060038512529 ()
  • 05060038512482 ()
  • 05707480129294 ()
4500M

  • Electrocardiographic electrode, single-use
Ambu White Sensor 4440M Electrod with wet gel and cloth backing. With center snap and PVC free. Radiolucent and MR Conditional. Packaging: 30 pouch/300 inner box/ 3000 carton
Ambu A/S
4440M
Not in Commercial Distribution

  • 05060038512239 ()
  • 05060038510716 ()
  • 05060038510594 ()
  • 05707480129287 ()
4440M

  • Electrocardiographic electrode, single-use
The zensor electrode array, electrocardiograph (ECG) and respiration electrode is a disposable, pre-gelled, self-adhesive, three lead electrode array, which is in contact with the patient's skin. The device is used in conjunction with the zensor device in order to monitor vital signs for ECG, respiration and motion for ambulatory and non-ambulatory patients in a home environment. This is a single use device and is intended to be used on an adult patient for a period of up to 6 days before a replacement is required.
INTELESENS LIMITED
PN1360
In Commercial Distribution

  • 05060484630099 ()


  • Electrocardiographic electrode, single-use
The Aingeal 3-Patch Electrode Array is an electrocardiograph (ECG), respiration and temperature electrode. It is a disposable, pre-gelled, self-adhesive, single lead electrode array, which is designed to be used in contact with the patient’s skin. The device is used in conjunction with the Aingeal Device in order to monitor vital signs for ECG, respiration, motion and temperature for ambulatory and non-ambulatory patients in a hospital environment. This is a single use device and is intended to be used on an adult patient for a period of up to 72 hours before a replacement is required.
INTELESENS LIMITED
PN1120
In Commercial Distribution

  • 25060484630031 ()
  • 15060484630034 ()
  • 05060484630037 ()


  • Electrocardiographic electrode, single-use
The zensor electrode array, electrocardiograph (ECG) and respiration electrode is a disposable, pre-gelled, self-adhesive, three lead electrode array, which is in contact with the patient's skin. The device is used in conjunction with the zensor device in order to monitor vital signs for ECG, respiration and motion for ambulatory and non-ambulatory patients in a home environment. This is a single use device and is intended to be used on an adult patient for a period of up to 72 hours before a replacement is required.
INTELESENS LIMITED
PN1088
In Commercial Distribution

  • 15060484630010 ()
  • 05060484630013 ()


  • Electrocardiographic electrode, single-use
Electrode, electrocardiograph-Pouch of 50
Hartman Medical Group LLC
001
In Commercial Distribution

  • 00850048235007 ()
  • 00850048235038 ()


  • Electrocardiographic electrode, single-use
Vital Signs™ Leg Attachment Pad for Corometrics™ Fetal Scalp Electrode Cable
AirLife Finland Oy
2464AAO-20
In Commercial Distribution

  • 20889483578947 ()
  • 10889483578940 ()
  • 10190752188181 ()
2464AAO-20

  • Electrocardiographic electrode, single-use
Single-use disposable precordial overlay ECG system
ENNOVEA MEDICAL, LLC
CQP-004-RT
Not in Commercial Distribution

  • 00869413000201 ()
  • 00869413000218 ()


  • Electrocardiographic electrode, single-use
DISPOSABLE SNAP ELECTRODE, FOAM/HYDROGEL ADHESIVE
MED-DYNE, INC.
DELF3000L
In Commercial Distribution

  • 00868795000250 ()


  • Electrocardiographic electrode, single-use
DISPOSABLE SNAP ELECTRODE, CLOTH/HYDROGEL ADHESIVE
MED-DYNE, INC.
DEL3000I
In Commercial Distribution

  • 00868795000243 ()


  • Electrocardiographic electrode, single-use
Disposable Snap Electrode, cloth/Hydrogel Adhesive - PACK OF 45
MED-DYNE, INC.
DEL3000A
In Commercial Distribution

  • 00868795000236 ()

  • Height: 1.25 Inch
  • Width: 1.25 Inch
DEL3000A

  • Electrocardiographic electrode, single-use
Disposable Snap Electrode, Cloth/Hydrogel Adhesive - PACK OF 45
MED-DYNE, INC.
DEL3000
In Commercial Distribution

  • 00868795000229 ()

  • Height: 1.25 Inch
  • Width: 0.875 Inch
DEL3000

  • Electrocardiographic electrode, single-use
GS27 Pre-gelled Disposable sEMG Electrodes
BIO-MEDICAL INSTRUMENTS, INC.
BMI GS27
In Commercial Distribution

  • 00867972000250 ()


  • Electrocardiographic electrode, single-use
The MERIDIAN Disposable Electrode Patch consists of four patches, two for the mother’s abdomen and one for each of her sides, which provides continuous fetal signal capture during fetal movement.
MINDCHILD MEDICAL
MDPA1
In Commercial Distribution

  • 00867696000345 ()
  • 00867696000338 ()
  • 00867696000321 ()


  • Electrocardiographic electrode, single-use
Bittium OmegaSnap Multi-CH Adapter
Bittium Biosignals Oy
Multi-CH Adapter
In Commercial Distribution

  • 06430035220700 ()
9404719

  • Electrocardiographic electrode, single-use
Bittium MiniSnap Sensitive 1-CH ECG Electrode
Bittium Biosignals Oy
1-CH ECG Electrode
In Commercial Distribution

  • 06430035220694 ()
9404718

  • Electrocardiographic electrode, single-use
3-CH ECG Electrode
Bittium Biosignals Oy
3-CH ECG Electrode
In Commercial Distribution

  • 06430035220687 ()
9404717

  • Electrocardiographic electrode, single-use
2-CH ECG Electrode
Bittium Biosignals Oy
2-CH ECG Electrode
In Commercial Distribution

  • 06430035220670 ()
9404716

  • Electrocardiographic electrode, single-use
Bittium OmegaSnap 1-CH Adapter
Bittium Biosignals Oy
1-CH Adapter
In Commercial Distribution

  • 06430035220588 ()
9400147

  • Electrocardiographic electrode, single-use
1-CH ECG Electrode
Bittium Biosignals Oy
1-CH ECG Electrode
In Commercial Distribution

  • 06430035220519 ()
9404644

  • Electrocardiographic electrode, single-use
The Fast-Fix ECG Electrode is a user-friendly, single-use electrode meant to use with Faros ECG devices. The electrode is affixed to the patient's chest, and it transfers the hearts biosignal from the body to the Faros ECG device.
Bittium Biosignals Oy
901155
In Commercial Distribution

  • 06430035220335 ()


  • Electrocardiographic electrode, single-use
3M™ Red Dot™ Resting EKG Electrode 2360
3M COMPANY
2360
In Commercial Distribution

  • 50707387472820 ()
  • 00707387472825 ()
  • 10707387472822 ()
2360

  • Electrocardiographic electrode, single-use
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