Invacare® Oxygen Analyzer

GUDID 00841447100737

INVACARE CORPORATION

Respiratory oxygen monitor, line-powered

• Primary Device ID: 00841447100737
• NIH Device Record Key: 95ebcf44-a170-44e0-a00e-7f3766b7a8fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invacare® Oxygen Analyzer
• Version Model Number: IRC450
• Company DUNS: 076916246
• Company Name: INVACARE CORPORATION
• 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: false
• 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

Customer Support Contacts

• Phone: +1(440)329-6000
• Email: orders@invacare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841447100737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112402

FDA Product Code

• CCL: ANALYZER, GAS, OXYGEN, GASEOUS-PHASE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-27

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