Gentle Vent™

GUDID 20721902350089

SUCTION GV100 GENTLE VENT PUMP 5PK 10L

MEDTRONIC, INC.

In-line backflow valve, single-use In-line backflow valve, single-use

• Primary Device ID: 20721902350089
• NIH Device Record Key: 5e22c4c9-34cb-4dc7-aca8-6352b4a8c650
• Commercial Distribution Discontinuation: 2017-10-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Gentle Vent™
• Version Model Number: GV100
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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: 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902350085 [Primary]
GS1	20721902350089 [Package]; Contains: 00721902350085; Package: PK [5 Units]; Discontinued: 2017-10-19; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012538

FDA Product Code

• DWF: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-04
• Device Publish Date: 2016-06-13

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