Ecogel 100

GUDID 00628055650331

5 Liter cubetainer

Eco-Med Pharmaceutical Inc

Coupling gel, non-sterile

• Primary Device ID: 00628055650331
• NIH Device Record Key: ff38c2d7-51be-4e16-b736-2c963321abac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ecogel 100
• Version Model Number: 30GS
• Company DUNS: 249183435
• Company Name: Eco-Med Pharmaceutical Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628055650331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961757

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-15
• Device Publish Date: 2016-08-23

On-Brand Devices [Ecogel 100]

• 00628055650386: 12x250ml case
• 00628055650379: 4x1 Gallon
• 00628055650362: Gallon Jug
• 00628055650355: 4x5 Liter
• 00628055650348: Single 5 Liter
• 00628055650331: 5 Liter cubetainer
• 00628055650324: 24x250ml case
• 00628055650317: 250ml bottle