1000 Anesthesia Replacement Oxygen Cell

GUDID 00815871020169

​DRE 1000 Labeled (MAX-1)

Avante

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

Devices Manufactured by Avante

• 00815871020091 - Disposable Monopolar Handswitching Pencil: 2020-03-02
• 00815871020190 - Compact FM: 2020-03-02
• 00815871020206 - Compact FM: 2020-03-02
• 00815871020213 - Compact FM: 2020-03-02
• 00815871020220 - Compact FM: 2020-03-02
• 00815871020237 - Compact Plus: 2020-03-02
• 00815871020244 - Compact Plus: 2020-03-02
• 00815871020251 - Compact Plus: 2020-03-02