Vesco Medical ENFit Tip Syringe VED-635

GUDID 10850801006353

35 mL ENFit Tip Syringe - Blister Pack

VESCO MEDICAL, LLC

ENFit oral/enteral syringe, single-use

• Primary Device ID: 10850801006353
• NIH Device Record Key: 39187e1b-9ab2-4509-88d7-9ec4a08cacff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vesco Medical ENFit Tip Syringe
• Version Model Number: VED-635
• Catalog Number: VED-635
• 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

Device Dimensions

• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter
• Total Volume: 35 Milliliter

Operating and Storage Conditions

• 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	00850801006356 [Primary]
GS1	10850801006353 [Package]; Contains: 00850801006356; Package: Case [500 Units]; In Commercial Distribution
GS1	20850801006350 [Package]; Contains: 00850801006356; Package: Inner Pack [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190502

FDA Product Code

• PNR: Enteral Syringes With Enteral Specific Connectors

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: 2023-04-14
• Device Publish Date: 2023-04-06

On-Brand Devices [Vesco Medical ENFit Tip Syringe]

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• 10850801006520: 20 mL ENFit Tip Feed and Flush Syringe w/ Transition Connector
• 10850801006513: 10 mL ENFit Tip Feed and Flush Syringe w/ Transition Connector
• 10850801006353: 35 mL ENFit Tip Syringe - Blister Pack
• 20850801006343: 20 mL ENFit Tip Syringe - Blister Pack
• 10850801006339: 10 mL ENFit Tip Syringe - Blister Pack
• 00850801006325: 5 mL ENFit Tip Syringe - Blister Pack
• 10850801006315: 60 mL ENFit Tip Syringe - Blister Pack
• 10810096150629: 5 mL ENFit Tip Feed and Flush Syringe w/ Transition Connector