FDA.reportPublic FDA data

Pharmaceutical Innovations

Primary DI
00300361000207
Brand
Pharmaceutical Innovations
Company
PHARMACEUTICAL INNOVATIONS INC
Model
UltraPhonic Conductivity Gel
Catalog number
36-1000-20
Device description
UltraPhonic Conductivity Gel, Aqueous Coupling Agent for Ultrasound and Electromedical Procedures, 20 ml Sterile Packet
Published
2016-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUIMedia,Coupling,Ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUIMedia, Coupling, UltrasoundRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10300361000204PackageGS125In Commercial Distribution
10300361000211PackageGS1200In Commercial Distribution
00300361000207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030036100020410300361000204
1030036100021110300361000211
00300361000207003003610002073003610002070300361000207

GMDN Terms#

Term, Definition table
TermDefinition
Coupling gel, sterileA sterile medium designed to be applied to a patient's skin surface to provide a coupling between an ultrasound transducer and the patient, allowing for the emission and reception of ultrasonic waves that pass through the skin during an ultrasound examination requiring sterile procedure. It is in the form of a non-sticky, drip resistant, fluid-like gel that has been thermally sterilized (contains no degradation products of radiation sterilization) that also assists the operator's ability to move the ultrasound transducer (probe) smoothly over the skin to better scan the site of interest. 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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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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