Inogen Tidal Assist Ventilator Controller VC-100

GUDID 00817131020216

Inogen Tidal Assist Ventilator Controller

INOGEN, INC.

Portable electric ventilator

• Primary Device ID: 00817131020216
• NIH Device Record Key: 1d79ae28-b482-4fbb-965c-7a55c23876a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inogen Tidal Assist Ventilator Controller
• Version Model Number: VC-100
• Catalog Number: VC-100
• Company DUNS: 136729634
• Company Name: INOGEN, INC.
• Device Count: 1
• DM Exempt: true
• 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 Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817131020216 [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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• 36642240001604 - SIMEOX: 2025-03-20 Simeox_H airway clearance device, with remote control, power supply, transport bag and user manual
• 36642240001772 - TUB25: 2025-03-20 1 single patient use expiratory kit, composed of 1 tube, 1 filter programmed to allow 25 therapy sessions and 3 reusable mouthpi
• 36642240001840 - SIMEOX 200: 2025-03-20 Simeox 200 airway clearance device, with remote control, power supply, transport bag and user manual. 3664224SIMEOX+KIT8F
• 00817131020414 - Inogen Rove 4: 2024-11-01 The Inogen Rove 4™ Portable Oxygen Concentrator system is used on a prescriptive basis by patients requiring supplemental oxyg
• 00817131020513 - Inogen Rove 6: 2024-11-01 2.1. The Inogen Rove 6™ Portable Oxygen Concentrator system is used on a prescriptive basis by patients requiring supplemental
• 00817131020223 - TAV 7ft O2 Delivery Tubing: 2020-03-30 TAV 7ft O2 Delivery Tubing, 10-09889-XX-01