1240 O2 DISS Regulator TAV

GUDID 00817131020254

1240 O2 DISS Regulator TAV, 10-09779-XX-01 and RP-1004

INOGEN, INC.

Oxygen quick-connect coupling, male

• Primary Device ID: 00817131020254
• NIH Device Record Key: fc57695a-7a11-40e1-bf4a-f32f90171445
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1240 O2 DISS Regulator TAV
• Version Model Number: 10-09779-XX-01
• Company DUNS: 136729634
• Company Name: INOGEN, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00817131020254 [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

Devices Manufactured by INOGEN, INC.

• 00817131020223 - TAV 7ft O2 Delivery Tubing: 2020-03-30 TAV 7ft O2 Delivery Tubing, 10-09889-XX-01
• 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
• 00817131020308 - TAV Nasal Interface: 2020-03-30 TAV Nasal Interface (10-09815-XX-01)
• 00817131020377 - Nasal Interface, 1PK: 2020-03-30 Nasal Interface, 1PK, RP-1009
• 00817131020384 - 7ft O2 Delivery Tube TAV, 1PK: 2020-03-30 7ft O2 Delivery Tube TAV, 1PK, RP-1010
• 00817131020339 - 25ft O2 Delivery Tube TAV, 1PK: 2020-03-30 25ft O2 Delivery Tube TAV, 1PK, RP-1011
• 00817131020346 - 50ft O2 Delivery Tube TAV, 1PK: 2020-03-30 50ft O2 Delivery Tube TAV, 1PK, RP-1012