APNEICARE CONNECTION CENTER/INTERNET ANALYSIS

GUDID G642CC1A0

Medical software used for oximetry analysis and reporting.

APNEICARE, LLC

Medical equipment clinical data interfacing software

• Primary Device ID: G642CC1A0
• NIH Device Record Key: 65ad99cd-74eb-4708-b638-0f0c0a8b41b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APNEICARE CONNECTION CENTER/INTERNET ANALYSIS
• Version Model Number: CCIA
• Company DUNS: 830722232
• Company Name: APNEICARE, LLC
• 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: false
• 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
HIBCC	G642CC1A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082968

FDA Product Code

• MNR: Ventilatory Effort Recorder

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: 2024-05-20
• Device Publish Date: 2024-05-10