1000 Anesthesia Replacement Oxygen Cell

GUDID 00815871020169

​DRE 1000 Labeled (MAX-1)

Avante

Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor

• Primary Device ID: 00815871020169
• NIH Device Record Key: 668b0277-b6b8-4e9e-908f-92db59f6ed8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1000 Anesthesia Replacement Oxygen Cell
• Version Model Number: ​R113P90-002​​
• Company DUNS: 178440426
• Company Name: Avante
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815871020169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972992

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: 2019-06-19
• Device Publish Date: 2016-09-23

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