Criticare

GUDID B4388100EP1US0

nGenuity with CO2 and Printer

CRITICARE TECHNOLOGIES, INC.

General-purpose multi-parameter bedside monitor

• Primary Device ID: B4388100EP1US0
• NIH Device Record Key: 58fba85e-f596-4d4e-9508-31c58c04af42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Criticare
• Version Model Number: nGenuity 8100EP1
• 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	B4388100EP1US0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030613

FDA Product Code

• MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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]

• D438506DNBUS0: Monitor with DOX SPO2, NIBP, HR with Bluetooth
• B4388100EUS0: nGenuity without Printer
• B4388100EPUS0: nGenuity with Printer
• B4388100EPST0: nGenuity with Printer and ST
• B4388100EP1US0: nGenuity with CO2 and Printer
• B4388100EP1ST0: nGenuity with CO2, Printer and ST
• B4388100E1US0: nGenuity with CO2
• B4388100E1ST0: nGenuity with CO2 and ST
• B438560DNUS0: Monitor with DOX SPO2, NIBP, and HR