FDA.reportPublic FDA data

E-Z-SCAN Low Viscosity UltraSound Gel

Primary DI
30815112021413
Brand
E-Z-SCAN Low Viscosity UltraSound Gel
Company
Bracco Diagnostics Inc.
Model
601002
Catalog number
601002
Device description
EZ Scan 8oz Tube
Published
2025-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
30815112021413PackageGS112In Commercial Distribution
10815112021419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081511202141330815112021413
1081511202141910815112021419

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, transcutaneous electrical stimulator) and the patient, allowing for the emission and reception of energy/signals (e.g., electrical current, light) that pass through the skin during an examination or treatment. 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume8Fluid Ounce

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
609-514-2200xx@xx.xx

Regulatory Flags#

DUNS number
849234661
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
true
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
10815112020214Fast Find Grid: Disposable CT Biopsy Grid6000016000012016-09-19
10815112021167Rounded Flexi Tip Adult Enema Tip9013019013012023-05-25
10815112021181Miller Enema Air Tip with Non-Latex Retention Cuff9012019012012023-05-25
10815112021198Miller Enema Air Tip with Retention Cuff9012029012022023-05-25
30815112021703Two Tank Shuttle Valve System7106027106022025-06-30
30815112021710DIN 477 High Pressure Hose for CO23905133905132025-06-30
30815112021291High Pressure Hose and Yoke7106037106032023-08-31
10815112021174Enema Kit: Empty Enema Bag Delivery System9003029003022023-05-25
1081511202120418 French Pediatric Flexi Tip9013089013082023-05-25
30815112020805High Pressure DISS Hose For CO27106047106042016-09-19
30815112020782Two Tank Shuttle Valve System7106027106022016-09-19
10815112020535E-Z-GEL UltraSound Gel6010016010012016-09-23
10815112020542E-Z-SCAN Low Viscosity UltraSound Gel6010026010022016-09-23
10815112020559E-Z-SCAN Low Viscosity UltraSound Gel6010036010032016-09-23
10815112020566E-Z-GEL UltraSound Gel6010046010042016-09-23
10815112021402E-Z-GEL UltraSound Gel6010016010012025-05-16
10815112021419E-Z-SCAN Low Viscosity UltraSound Gel6010026010022025-05-16
10815112021426E-Z-SCAN Low Viscosity UltraSound Gel6010036010032025-05-16
10815112021433E-Z-GEL UltraSound Gel6010046010042025-05-16
10815112020856"""Y"" Connector with Tubing"9004029004022016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344130252MEDLINEMEDLINE INDUSTRIES, INC.MUI2026-04-09
10197344130269MEDLINEMEDLINE INDUSTRIES, INC.MUI2026-01-23
00197344130279MEDLINEMEDLINE INDUSTRIES, INC.MUI2026-01-23
10665973032631DukalDukal LLCMUI2026-01-12
10665973032648DukalDukal LLCMUI2026-01-12
10665973032655DukalDukal LLCMUI2026-01-12
10665973032662DukalDukal LLCMUI2026-01-12
20665973032638DukalDukal LLCMUI2026-01-12
20665973032645DukalDukal LLCMUI2026-01-12
30665973032659DukalDukal LLCMUI2026-01-12
30665973032666DukalDukal LLCMUI2026-01-12
10815112021402E-Z-GEL UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
10815112021419E-Z-SCAN Low Viscosity UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
10815112021426E-Z-SCAN Low Viscosity UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
10815112021433E-Z-GEL UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021406E-Z-GEL UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021420E-Z-SCAN Low Viscosity UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021437E-Z-GEL UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
10197106849064CARDINAL HEALTHCardinal Health 200, LLCMUI2025-01-09
10888277629844MEDLINEMEDLINE INDUSTRIES, INC.MUI2025-01-09
20888277629841MEDLINEMEDLINE INDUSTRIES, INC.MUI2025-01-09
00850030915207RichmarSouth Dakota Partners Inc.MUI2023-08-02
00848340014857Asonic GelADVANCE MEDICAL DESIGNS, INC.MUI2023-06-13
10848340014854Asonic GelADVANCE MEDICAL DESIGNS, INC.MUI2023-06-13
10080196306237MedlineMEDLINE INDUSTRIES, INC.MUI2023-01-04
40080196306238MedlineMEDLINE INDUSTRIES, INC.MUI2023-01-04
00810113688473ManaMed IncManamed, Inc.MUI2022-12-31
10193489025293MedlineMEDLINE INDUSTRIES, INC.MUI2022-12-02
30193489025297MedlineMEDLINE INDUSTRIES, INC.MUI2022-12-02
20612479262106McKessonMCKESSON MEDICAL-SURGICAL INC.MUI2022-09-28