SIMEOX SIMEOX_H

GUDID 36642240001604

Simeox_H airway clearance device, with remote control, power supply, transport bag and user manual

INOGEN, INC.

Vacuum-assisted airway secretion-clearing system

• Primary Device ID: 36642240001604
• NIH Device Record Key: 655bdb9d-2cb2-4c2b-81e7-05cf941e3d9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIMEOX
• Version Model Number: SIMEOX
• Catalog Number: SIMEOX_H
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	36642240001604 [Primary]

FDA Product Code

• SDT: Intra-Pulmonary Percussive Vibration (Ipv) Devices

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: 2025-03-20
• Device Publish Date: 2025-03-12

Devices Manufactured by INOGEN, INC.

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• 36642240000232 - TUB10: 2025-03-20 1 single patient use expiratory kit, composed of 1 tube, 1 filter programmed to allow 10 therapy sessions and 10 disposable mout
• 36642240000928 - SIMEOX 200: 2025-03-20 Simeox 200 airway clearance device with installed battery, remote control, power supply, transport bag and user manual
• 36642240001604 - SIMEOX: 2025-03-20Simeox_H airway clearance device, with remote control, power supply, transport bag and user manual
• 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