Nasal Interface, 3Pk RP-1000

GUDID 00817131020315

Nasal Interface 3Pk, RP-1000

INOGEN, INC.

CPAP/BPAP nasal mask, reusable

• Primary Device ID: 00817131020315
• NIH Device Record Key: 34e497db-e2b4-44a5-bc46-91febd37061f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nasal Interface, 3Pk
• Version Model Number: RP-1000
• Catalog Number: RP-1000
• 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: true
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817131020315 [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: 2020-03-23
• Device Publish Date: 2020-03-13

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