Eleview

GUDID 05391530190008

5 Ampoules, 10 mL each. To facilitate endoscopic resection procedures.

COSMO TECHNOLOGIES LIMITED

Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel

• Primary Device ID: 05391530190008
• NIH Device Record Key: 9ba76469-0be5-4058-b587-88d8b0103c86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eleview
• Version Model Number: 9000020
• Company DUNS: 989891457
• Company Name: COSMO TECHNOLOGIES LIMITED
• Device Count: 5
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391530190008 [Unit of Use]
GS1	05391530190367 [Primary]

FDA Product Code

• PLL: Submucosal Injection Agent

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-05
• Device Publish Date: 2021-03-28

On-Brand Devices [Eleview]

• 05391530190015: A sterile solution intended to be injected via an endoscopic injection needle into the submucosa
• 05391530190008: 5 Ampoules, 10 mL each. To facilitate endoscopic resection procedures.
• 05391530190053: 2 Ampoules, 10 mL each. To facilitate endoscopic resection procedures. For sample use only, not