Inca

GUDID 20888937009501

Replacement Set 10.5F

Coopersurgical, Inc.

CPAP nasal oxygen cannula

• Primary Device ID: 20888937009501
• NIH Device Record Key: 098b7eb3-7857-4d60-a212-5806759352f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inca
• Version Model Number: 44-0710
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	20888937009501 [Package]; Contains: 60888937009509; Package: [5 Units]; In Commercial Distribution
GS1	60888937009509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911780

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-08

On-Brand Devices [Inca]

• 20888937009563: Extra-Large Accessory Pack
• 20888937009556: Large Accessory Pack
• 20888937009549: Small Accessory Pack
• 20888937009532: Extra-Small Accessory Pack
• 20888937009525: Replacement Set 15F
• 20888937009518: Replacement Set 12F
• 20888937009501: Replacement Set 10.5F
• 20888937009495: Replacement Set 9F
• 20888937009488: Replacement Set 7.5F
• 20888937009471: Complete Set 15F
• 20888937009464: Complete Set 12F
• 20888937009457: Complete Set 10.5F
• 20888937009440: Complete Set 9F
• 20888937009433: Complete Set 7.5F