Nasal Interface, 1PK RP-1009

GUDID 00817131020377

Nasal Interface, 1PK, RP-1009

INOGEN, INC.

CPAP/BPAP nasal mask, reusable

• Primary Device ID: 00817131020377
• NIH Device Record Key: d8284a4a-b690-488f-84ee-7e898563ea5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nasal Interface, 1PK
• Version Model Number: RP-1009
• Catalog Number: RP-1009
• Company DUNS: 136729634
• Company Name: INOGEN, 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: 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817131020377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152664

FDA Product Code

• ONZ: Mechanical Ventilator

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: 2020-03-30
• Device Publish Date: 2020-03-20

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• 00817131020230 - TAV 25ft O2 Delivery Tubing: 2020-03-30 TAV 25ft O2 Delivery Tubing, 10-09890-XX-01
• 00817131020247 - TAV 50ft O2 Delivery Tubing: 2020-03-30 TAV 50ft O2 Delivery Tubing, 10-09891-XX-01
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