FDA.reportPublic FDA data

VERMED

Primary DI
15060441915464
Brand
VERMED
Company
NISSHA MEDICAL TECHNOLOGIES LTD
Model
F7751
Catalog number
4011048C
Device description
Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneous cardiac stimulation and ECG monitoring, with direct connection to cables and defibrillators
Published
2018-01-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LDDDc-Defibrillator, Low-Energy, (Including Paddles)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDDDc-Defibrillator, Low-Energy, (Including Paddles)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103783000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103783000EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRICFiab Spa2011-06-16LDD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35060441915468PackageGS110Not in Commercial Distribution
15060441915464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3506044191546835060441915468
1506044191546415060441915464

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive skin pad, single-useA noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., paddle-type defibrillator electrode) and the skin surface. It is available in various forms such as a thickened gel or polymer medium reinforced by a non-woven material, an adhesive pad/patch, or an absorbent material (e.g., felt) intended to be soaked in a conduction fluid. This is a single-use device.

Regulatory Flags#

DUNS number
671405566
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060441917826swaromed10366000045C2026-04-07
15060441918212swaromed40366000578C2026-04-07
15060441918229swaromed40666000581C2026-04-07
15060441918236swaromed40096000582C2026-04-07
15060441918250swaromed40606000588C2026-04-07
15060441918755swaromed40406001237C2026-04-07
15060842920197N/AGX1-1285H2025-06-18
15060842920210N/AGX1-1280H2025-06-18
35060842920191N/AGX1-1285H2025-06-18
35060842920214N/AGX1-1280H2025-06-18
15060842920234Corpuls1019CO19101.192025-02-18
35060842920238Corpuls1019CO19101.192025-02-18
15060842920142DrägerFW50DR7000018722024-03-01
15060842920159DrägerFW32PDR7000018732024-03-01
35060842920146DrägerFW50DR7000018722024-03-01
35060842920153DrägerFW32PDR7000018732024-03-01
15060441915105VERMEDF7957W4011003C2018-01-11
15060441915174VERMEDF79504010989C2018-01-08
15060441915181VERMEDF79514010990C2018-01-08
15060441915198VERMEDF79524010991C2018-01-08

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Primary DI, Brand, Company table
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00817392025593UnipowerUNIPOWER CORPORATIONLDD2024-01-10
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00817392025616UnipowerUNIPOWER CORPORATIONLDD2024-01-10
10888277634930MedlineMEDLINE INDUSTRIES, INC.LDD2021-10-22
10888277634954MedlineMEDLINE INDUSTRIES, INC.LDD2021-10-22
10888277634947MedlineMEDLINE INDUSTRIES, INC.LDD2021-09-16
00817392025289UnipowerUNIPOWER CORPORATIONLDD2021-04-30
07613365002737Tempus LS-MANUALSchiller AGLDD2020-08-11
08054242441765NAFIAB SPALDD2020-04-12
08054242441772NAFIAB SPALDD2020-04-12
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08054242441826NAFIAB SPALDD2020-04-12
08054242441833NAFIAB SPALDD2020-04-12
08054242441840NAFIAB SPALDD2020-04-12
08054242441857NAFIAB SPALDD2020-04-12
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08054242446449NAFIAB SPALDD2020-04-12
08054242446456NAFIAB SPALDD2020-04-12