FDA.reportPublic FDA data

Pharmaceutical Innovations

Primary DI
10300361100034
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
Rx
false
OTC
false
Sterile
false
Single use
false

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.

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

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
00300361100037Pharmaceutical 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