Saros Oxygen Concentrator

GUDID M7669400SEQ0

Portable Oxygen Concentrator 1-3 LPM, Continuous and Pulse Dose Settings

CAIRE INC.

Mobile/portable oxygen concentrator

• Primary Device ID: M7669400SEQ0
• NIH Device Record Key: f04d4737-a374-4c20-b7fd-0e021499b1f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Saros Oxygen Concentrator
• Version Model Number: 9400-SEQ
• Company DUNS: 807537683
• Company Name: CAIRE 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7669400SEQ0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083163

FDA Product Code

• CAW: Generator, Oxygen, Portable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-20
• Device Publish Date: 2015-07-01

On-Brand Devices [Saros Oxygen Concentrator]

• M7669400SEQ0: Portable Oxygen Concentrator 1-3 LPM, Continuous and Pulse Dose Settings
• M7669400RSEQ0: Portable Oxygen Concentrator 1-3 LPM, Continuous and Pulse Dose Settings, Refurbished