Inogen Tidal Assist Ventilator System VS-100

GUDID 00817131020209

Inogen Tidal Assist Ventilator System, VS-100

INOGEN, INC.

Portable electric ventilator

• Primary Device ID: 00817131020209
• NIH Device Record Key: eb0d65b6-f47f-4ada-829f-ae8bbc8194fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inogen Tidal Assist Ventilator System
• Version Model Number: VS-100
• Catalog Number: VS-100
• Company DUNS: 136729634
• Company Name: INOGEN, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817131020209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152664

FDA Product Code

• ONZ: Mechanical Ventilator

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: 2020-03-23
• Device Publish Date: 2020-03-13

Devices Manufactured by INOGEN, INC.

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• 00817131020230 - TAV 25ft O2 Delivery Tubing: 2020-03-30 TAV 25ft O2 Delivery Tubing, 10-09890-XX-01
• 00817131020247 - TAV 50ft O2 Delivery Tubing: 2020-03-30 TAV 50ft O2 Delivery Tubing, 10-09891-XX-01
• 00817131020308 - TAV Nasal Interface: 2020-03-30 TAV Nasal Interface (10-09815-XX-01)
• 00817131020377 - Nasal Interface, 1PK: 2020-03-30 Nasal Interface, 1PK, RP-1009
• 00817131020384 - 7ft O2 Delivery Tube TAV, 1PK: 2020-03-30 7ft O2 Delivery Tube TAV, 1PK, RP-1010
• 00817131020339 - 25ft O2 Delivery Tube TAV, 1PK: 2020-03-30 25ft O2 Delivery Tube TAV, 1PK, RP-1011
• 00817131020346 - 50ft O2 Delivery Tube TAV, 1PK: 2020-03-30 50ft O2 Delivery Tube TAV, 1PK, RP-1012