Vesco Medical ENFit Low Dose Tip Syringe VED-601EO

GUDID 20850801006381

1 mL ENFit Low Dose Tip Syringe

VESCO MEDICAL, LLC

Oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use

• Primary Device ID: 20850801006381
• NIH Device Record Key: a2b5d79b-3c98-4944-8465-8c7f479bdcf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vesco Medical ENFit Low Dose Tip Syringe
• Version Model Number: VED-601EO
• Catalog Number: VED-601EO
• Company DUNS: 079527070
• Company Name: VESCO MEDICAL, LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6149145991
• Email: info@vescomedical.com
• Phone: 6149145991
• Email: info@vescomedical.com
• Phone: 6149145991
• Email: info@vescomedical.com
• Phone: 6149145991
• Email: info@vescomedical.com
• Phone: 6149145991
• Email: info@vescomedical.com
• Phone: 6149145991
• Email: info@vescomedical.com
• Phone: 6149145991
• Email: info@vescomedical.com
• Phone: 6149145991
• Email: info@vescomedical.com
• Phone: 6149145991
• Email: info@vescomedical.com
• Phone: 6149145991
• Email: info@vescomedical.com
• Phone: 6149145991
• Email: info@vescomedical.com
• Phone: 6149145991
• Email: info@vescomedical.com
• Phone: 6149145991
• Email: info@vescomedical.com
• Phone: 6149145991
• Email: info@vescomedical.com
• Phone: 6149145991
• Email: info@vescomedical.com
• Phone: 6149145991
• Email: info@vescomedical.com
• Phone: 6149145991
• Email: info@vescomedical.com

Device Dimensions

• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850801006387 [Primary]
GS1	10850801006384 [Package]; Contains: 00850801006387; Package: Inner Pack [200 Units]; In Commercial Distribution
GS1	20850801006381 [Package]; Contains: 10850801006384; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161979

FDA Product Code

• PNR: Enteral Syringes With Enteral Specific Connectors

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-22
• Device Publish Date: 2017-10-05

On-Brand Devices [Vesco Medical ENFit Low Dose Tip Syringe]

• 20850801006398: 3 mL ENFit Low Dose Tip Syringe
• 20850801006381: 1 mL ENFit Low Dose Tip Syringe