E-Z-GEL UltraSound Gel 601004

GUDID 30815112021437

EZ Gel 5L

Bracco Diagnostics Inc.

Skin topical coupling gel

• Primary Device ID: 30815112021437
• NIH Device Record Key: a9e6ba3b-fdae-4ea6-bb55-787470c341e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-Z-GEL UltraSound Gel
• Version Model Number: 601004
• Catalog Number: 601004
• Company DUNS: 849234661
• Company Name: Bracco Diagnostics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx

Device Dimensions

• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815112021433 [Primary]
GS1	20815112021430 [Package]; Contains: 10815112021433; Package: Box [1 Units]; In Commercial Distribution
GS1	30815112021437 [Package]; Contains: 10815112021433; Package: Box [4 Units]; In Commercial Distribution

FDA Product Code

• MUI: Media,Coupling,Ultrasound

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-26
• Device Publish Date: 2025-05-16

On-Brand Devices [E-Z-GEL UltraSound Gel]

• 30815112021437: EZ Gel 5L
• 30815112021406: EZ Gel 8oz