Criticare Gemini

GUDID B438506DNP3US0

Monitor with DOX SPO2, NIBP, HR, and Printer

CRITICARE TECHNOLOGIES, INC.

Multiple vital physiological parameter monitoring system, clinical

• Primary Device ID: B438506DNP3US0
• NIH Device Record Key: cda917f9-5112-491d-84ef-0a1270cb191e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Criticare Gemini
• Version Model Number: VitalCare 506DNP3
• Company DUNS: 080402199
• Company Name: CRITICARE TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B438506DNP3US0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K884216

FDA Product Code

• DQA: Oximeter

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: 2024-07-16
• Device Publish Date: 2024-07-08

On-Brand Devices [Criticare Gemini]

• B438506LNVP30: Monitor with Nellcor SPO2, NIBP, HR, Temp, and Printer
• B438506LNP30: Monitor with Nellcor SPO2, NIBP, HR, and Printer
• B438506DNVP30: Monitor with DOX SPO2, NIBP, HR, Printer and Temp
• B438506DNP3US0: Monitor with DOX SPO2, NIBP, HR, and Printer