FDA.reportPublic FDA data

Pharmaceutical Innovations

Primary DI
00300361100037
Brand
Pharmaceutical Innovations
Company
PHARMACEUTICAL INNOVATIONS INC
Model
UltraWarmer Gel Warmer - Red
Catalog number
36-1100-03
Device description
UltraWarmer Ultrasound Gel Warmer for one: 250ml bottle. Red.
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFCWarmer, Anesthetic Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFCWarmer, Anesthetic TubeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10300361100034PackageGS11In Commercial Distribution
00300361100037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030036110003410300361100034
00300361100037003003611000373003611000370300361100037

GMDN Terms#

Term, Definition table
TermDefinition
Gel warmerA portable, mains electricity (AC-powered) device intended to be used to prewarm gels (e.g., ultrasonic coupling gels, vaginal exploratory gels) prior to patient application. It is typically a tabletop device that includes a recess or a well for placement of a gel container, a heating element, a thermostat, and operating controls.

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017901930C-WarmerDXM CO., LTDEFC2024-07-15
E22190021Caps WarmerVOCO GmbHEFC2024-05-07
08800017900087C-WarmerDXM CO., LTDEFC2023-06-19
08800017900094C-WarmerDXM CO., LTDEFC2023-06-19
08800017900100C-WarmerDXM CO., LTDEFC2023-06-19
08800017900117C-WarmerDXM CO., LTDEFC2023-06-19
E22190031Caps WarmerVOCO GmbHEFC2021-02-02
E22160631VisCalor bulkVOCO GmbHEFC2019-05-10
E22190011Caps WarmerVOCO GmbHEFC2017-12-21
D8691100000AdDentADDENT, INC.EFC2017-06-01
10300361100034Pharmaceutical InnovationsPHARMACEUTICAL INNOVATIONS INCEFC2016-09-20
00300361100020Pharmaceutical InnovationsPHARMACEUTICAL INNOVATIONS INCEFC2016-09-14
10300361100027Pharmaceutical InnovationsPHARMACEUTICAL INNOVATIONS INCEFC2016-09-14
00300361100013Pharmaceutical InnovationsPHARMACEUTICAL INNOVATIONS INCEFC2016-09-01
10300361100010Pharmaceutical InnovationsPHARMACEUTICAL INNOVATIONS INCEFC2016-09-01