Cognito Health

GUDID 04719889980025

Cognito Health Inc.

Nurse call system alarm

• Primary Device ID: 04719889980025
• NIH Device Record Key: 10ccca5b-2aa2-4769-8405-60cae929115a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cognito Health
• Version Model Number: BA6E-31
• Company DUNS: 657327248
• Company Name: Cognito Health Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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
GS1	04719889980025 [Primary]
GS1	14719889980022 [Package]; Package: Case [6 Units]; In Commercial Distribution
GS1	24719889980029 [Package]; Contains: 14719889980022; Package: Carton [3 Units]; In Commercial Distribution

FDA Product Code

• PJO: Fall Prevention Alarm/Sensor Combination Attached Or Unattached

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: 2022-12-05
• Device Publish Date: 2022-11-25

On-Brand Devices [Cognito Health]

• 04719889980056: BA6E-32
• 14719889980046: BA6E-31
• 14719889980039: BA6E-32
• 04719889980025: BA6E-31
• 14719889980015: P7FD-21