FDA.reportPublic FDA data

FANTABSTIC DANLEE ELECTRODE RESTING TAB (100 PER POUCH)

Primary DI
00816310022997
Brand
FANTABSTIC DANLEE ELECTRODE RESTING TAB (100 PER POUCH)
Company
DANLEE MEDICAL PRODUCTS, INC
Model
ED3000
Published
2020-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Single use
true

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931457000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931457000NDM SILVON ECG ELECTRODESNdm Acquisition Corp.1993-11-23DRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816310022994PackageGS15In Commercial Distribution
20816310022991PackageGS110In Commercial Distribution
00816310022997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081631002299410816310022994
2081631002299120816310022991
00816310022997008163100229978163100229970816310022997

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, single-useA non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature41 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
878130871
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816310023840DANLEE MEDICAL KITSAMPLE AMBU R SERIESS0B2S7ABWS2026-02-13
00816310023833DANLEE MEDICAL KIT470-0104-012025-10-28
00816310023826DANLEE MEDICAL KITCK-002-NRB2025-03-13
00816310023819DANLEE MEDICAL KITD022S5AB-1D022S5AB-12024-10-30
00816310023802DANLEE MEDICAL KITD0B1G5AB-12024-10-10
00816310023796DANLEE MEDICAL KITS000G5DDAS2024-10-09
00816310023789DANLEE MEDICAL KITD000S5ABUVZ2024-08-06
00816310023772DANLEE MEDICAL KITS000P5DDABWGG2024-06-14
00816310023758DANLEE MEDICAL KITD0B1S7ABUV2024-02-21
00816310023765DANLEE MEDICAL KITS0B1S52024-02-21
00816310023741DANLEE MEDICAL KITHTC-0012023-12-14
00816310023734DANLEE MEDICAL KITS00000AGG2023-07-14
00816310023727DANLEE MEDICAL KITD022G5ABKV2023-04-25
00816310023710DANLEE MEDICAL KITD0B1P7ABV2023-04-05
00816310023703DANLEE MEDICAL KITMED6G022G5ABV2023-03-31
00816310023697DANLEE MEDICAL KITD0B1P7AVZ2023-03-14
00816310023680DANLEE MEDICAL KITGS021G5ABUVW2023-01-23
00816310023666DANLEE MEDICAL KITGS000G5ABUVW2022-10-03
00816310023673DANLEE MEDICAL KITG0B1G5AV2022-10-03
00816310023659DANLEE MEDICAL KITS0B2S5ABMSW2022-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060038511034Ambu® WhiteSensor 40554Ambu A/SDRX2026-08-07
00851491007555AccuSensorLynn Medical Instrument Co.DRX2026-07-28
00851491007562AccuSensorLynn Medical Instrument Co.DRX2026-07-24
G828HARNESS0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
20192253016663KendallCardinal Health 200, LLCDRX2024-02-28
20192253016670KendallCardinal Health 200, LLCDRX2024-02-28
20192253017424KendallCardinal Health 200, LLCDRX2024-02-28
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
10841522130298Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCDRX2023-02-23
08033003267424NAFIAB SPADRX2021-03-31
20192253016755KendallCardinal Health 200, LLCDRX2021-02-23
20192253017196KendallCardinal Health 200, LLCDRX2020-11-17
08906035281044Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281174Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281501Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281525Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281532Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281549Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281587Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281600Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282829Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282881Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282898Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282904Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282911Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282942Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282959Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20