FDA.reportPublic FDA data

Pharmaceutical Innovations

Primary DI
00300361300253
Brand
Pharmaceutical Innovations
Company
PHARMACEUTICAL INNOVATIONS INC
Model
UltraPhonic Focus Gel Pad
Catalog number
36-1300-25
Device description
UltraPhonic Focus Conforming Gel Pad, 2.5 cm x 9 cm
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10300361300250PackageGS15In Commercial Distribution
00300361300253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030036130025010300361300250
00300361300253003003613002533003613002530300361300253

GMDN Terms#

Term, Definition table
TermDefinition
Skin topical coupling gelA medium designed to be applied to a patient's unbroken skin surface (excludes the eye surface) to provide a coupling between an analytical or therapeutic device (e.g., ultrasound transducer, optical glucose monitoring system,) and the patient, allowing for the emission and reception of energy/signals (e.g., electrical current, light, blood gas) that pass through the skin during an examination or treatment. Also known as contact gel, it is in the form of a fluid-like gel that may also assist in moving the parent device smoothly over the skin. It may be used by a healthcare professional in a clinical setting and layperson in the home. After application, this device cannot be reused.

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

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
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
00300361150254Pharmaceutical InnovationsGAMMA Massage & Ultrasound Gel36-1150-252016-09-14

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Primary DI, Brand, Company table
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20665973032638DukalDukal LLCMUI2026-01-12
20665973032645DukalDukal LLCMUI2026-01-12
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30665973032666DukalDukal LLCMUI2026-01-12
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