Gentle Vent™

Basic Information

• Brand Name: Gentle Vent™
• Primary DI: 00721902350085
• Version / Model: GV100
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-13
• Public Version: 4
• Public Version Date: 2019-03-04
• Public Version Status: Update
• Public Device Record Key: 5e22c4c9-34cb-4dc7-aca8-6352b4a8c650
• Distribution End Date: 2017-10-19

Device Description

SUCTION GV100 GENTLE VENT PUMP 5PK 10L

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWF	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	Cardiovascular	870.4210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34099	In-line backflow valve, single-use	A general-purpose device used in medical or laboratory tubing to prevent the backflow of gases or liquids. It will typically have a small ball or a leaf valve that instantly closes should a retrograde pressure (backflow) occur. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20721902350089	GS1	PK	5	Not in Commercial Distribution	2017-10-19
Primary	00721902350085	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K012538	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 40 Degrees Celsius