Ecogel 200

GUDID 00628055650461

4x5 Liter

Eco-Med Pharmaceutical Inc

Coupling gel, non-sterile Coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel

• Primary Device ID: 00628055650461
• NIH Device Record Key: 2ecd27e3-d9b9-432c-80ea-6a601d0aeb8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ecogel 200
• Version Model Number: 40JM
• 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	00628055650461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955246

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 200]

• 00628055650928: 250ml bottle
• 00628055650911: 1 Liter
• 00628055650652: 4x5 Liter
• 00628055650645: Single 5 Liter
• 00628055650638: 5 Liter cubetainer
• 00628055650621: 24x250ml case
• 00628055650614: 250ml bottle
• 00628055650461: 4x5 Liter
• 00628055650454: Single 5 Liter
• 00628055650447: 5 Liter cubetainer
• 00628055650430: 12x250ml case
• 00628055650423: 24x250ml case
• 00628055650416: 250ml bottle
• 00628055650713: High-Viscosity Blue 5L Cube
• 00628055650973: High-Viscosity Clear
• 00628055650706: High-Viscosity Blue 250ml Bottle
• 00628055650683: Clear 20g Packet
• 00628055650584: High-Viscosity Blue 20g Packet
• 00628055650553: High-Viscosity Clear 20g Packet
• 00628055650492: Blue 20g Packet