FDA.reportPublic FDA data

Pharmaceutical Innovations

Primary DI
10300363000387
Brand
Pharmaceutical Innovations
Company
PHARMACEUTICAL INNOVATIONS INC
Model
Lectron II Electrode Conductivity Gel
Catalog number
36-3000-38
Device description
Lectron II Electrode Conductivity Gel: 2.5 Gallon
Published
2019-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GYBMedia, Electroconductive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYBMedia, ElectroconductiveNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10300363000387PackageGS11In Commercial Distribution
00300363000380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030036300038710300363000387
00300363000380003003630003803003630003800300363000380

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive mediumA non-sterile substance intended to be used as a medium for the efficient transmission of electrical signals between an electrode and the body, and for the reduction of the isolation properties of the skin. It is typically in the form of a gel, paste, spray or cream and is usually used in electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
973-242-2900info@pharminnovations.com

Regulatory Flags#

DUNS number
067486548
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00300361000047Pharmaceutical InnovationsUltraPhonic Conductivity Gel36-1000-042016-09-20
00300361000122Pharmaceutical InnovationsUltraPhonic Conductivity Gel36-1000-25B2016-09-14
00300361000252Pharmaceutical InnovationsUltraPhonic Conductivity Gel36-1000-252016-09-14
00300361000603Pharmaceutical InnovationsUltraPhonic Conductivity Gel36-1000-602016-09-20
00300361000900Pharmaceutical InnovationsUltraPhonic Conductivity Gel36-1000-902016-09-14
00300361004052Pharmaceutical InnovationsVetGel Veterinary Ultrasound Gel36-1004-052016-09-20
00300361200607Pharmaceutical InnovationsUltraPhonic FREE Conductivity Gel36-1200-602016-09-14
00300361300154Pharmaceutical InnovationsUltraPhonic Focus Gel Pad36-1300-152016-09-14
00300361300253Pharmaceutical InnovationsUltraPhonic Focus Gel Pad36-1300-252016-09-14
00300361305029Pharmaceutical InnovationsUltraPhonic Focus Thin Gel Pad36-1305-022018-07-10
00300361600056Pharmaceutical InnovationsPhoton Transmitting Gel36-1600-052016-09-21
00300361000054Pharmaceutical InnovationsUltraPhonic Conductivity Gel36-1000-052016-09-20
00300361001044Pharmaceutical InnovationsUltraPhonic Scanning Gel36-1001-042016-09-20
00300361001051Pharmaceutical InnovationsUltraPhonic Scanning Gel36-1001-052016-09-20
00300361001259Pharmaceutical InnovationsUltraPhonic Scanning Gel 36-1001-252016-09-14
00300361001907Pharmaceutical InnovationsUltraPhonic Scanning Gel36-1001-902016-09-14
00300361111057Pharmaceutical InnovationsOther-Sonic High Viscosity Generic Ultrasound Gel36-1111-052016-09-21
00300361111255Pharmaceutical InnovationsOther-Sonic High Viscosity Generic Ultrasound Gel36-1111-252016-09-14
00300361111606Pharmaceutical InnovationsOther-Sonic High Viscosity Generic Ultrasound Gel36-1111-602016-09-14
00300361150049Pharmaceutical InnovationsGAMMA Massage & Ultrasound Gel36-1150-042016-09-21

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