Lutech

GUDID B299780LICOP0

Multi-parameter patient monitor. 780-L-I-CO-P

LUTECH INDUSTRIES INC

Transportable physiologic monitoring system

• Primary Device ID: B299780LICOP0
• NIH Device Record Key: 6d08128c-3d0d-4c34-89b1-e6a08bdc2163
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lutech
• Version Model Number: Datalys 780
• Company DUNS: 078698036
• Company Name: LUTECH INDUSTRIES 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B299780LICOP0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150691

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-12

On-Brand Devices [Lutech]

• B299LT300SD0: Digital video colposcope.
• B299LT300HD0: High definition digital video colposcope.
• B299LT3000: Digital Video Colposcope
• B299780NPMP0: Multi-parameter patient monitor. 780-N-pM-P
• B299780NPMO2P0: Multi-parameter patient monitor. 780-N-pMO2-P
• B299780NPMO20: Multi-parameter patient monitor. 780-N-pMO2
• B299780NPM0: Multi-parameter patient monitor. 780-N-pM
• B299780NP0: Multi-parameter patient monitor. 780-N-P
• B299780NIPMP0: Multi-parameter patient monitor. 780-N-I-pM-P
• B299780NIPMO2P0: Multi-parameter patient monitor. 780-N-I-pMO2-P
• B299780NIPMO20: Multi-parameter patient monitor. 780-N-I-pMO2
• B299780NIPM0: Multi-parameter patient monitor. 780-N-I-pM
• B299780NIP0: Multi-parameter patient monitor. 780-N-I-P
• B299780NICP0: Multi-parameter patient monitor. 780-N-IC-P
• B299780NICOP0: Multi-parameter patient monitor. 780-N-I-CO-P
• B299780NICO0: Multi-parameter patient monitor. 780-N-I-CO
• B299780NICCOP0: Multi-parameter patient monitor. 780-N-IC-CO-P
• B299780NICCO0: Multi-parameter patient monitor. 780-N-IC-CO
• B299780NIC0: Multi-parameter patient monitor. 780-N-IC
• B299780NI0: Multi-parameter patient monitor. 780-N-I
• B299780NCP0: Multi-parameter patient monitor. 780-N-C-P
• B299780NCO0: Multi-parameter patient monitor. 780-N-CO
• B299780NC0: Multi-parameter patient monitor. 780-N-C
• B299780N0: Multi-parameter patient monitor. 780-N
• B299780MPMP0: Multi-parameter patient monitor. 780-M-pM-P
• B299780MPMO2P0: Multi-parameter patient monitor. 780-M-pMO2-P
• B299780MPMO20: Multi-parameter patient monitor. 780-M-pMO2
• B299780MPM0: Multi-parameter patient monitor. 780-M-pM
• B299780MP0: Multi-parameter patient monitor. 780-M-P
• B299780MIPMP0: Multi-parameter patient monitor. 780-M-I-pM-P
• B299780MIPMO2P0: Multi-parameter patient monitor. 780-M-I-pMO2-P
• B299780MIPMO20: Multi-parameter patient monitor. 780-M-I-pMO2
• B299780MIPM0: Multi-parameter patient monitor. 780-M-I-pM
• B299780MIP0: Multi-parameter patient monitor. 780-M-I-P
• B299780MICP0: Multi-parameter patient monitor. 780-M-IC-P
• B299780MICOP0: Multi-parameter patient monitor. 780-M-I-CO-P
• B299780MICO0: Multi-parameter patient monitor. 780-M-I-CO
• B299780MICCOP0: Multi-parameter patient monitor. 780-M-IC-CO-P
• B299780MICCO0: Multi-parameter patient monitor. 780-M-IC-CO
• B299780MIC0: Multi-parameter patient monitor. 780-M-IC
• B299780MI0: Multi-parameter patient monitor. 780-M-I
• B299780MCP0: Multi-parameter patient monitor. 780-M-C-P
• B299780MC0: Multi-parameter patient monitor. 780-M-C
• B299780M0: Multi-parameter patient monitor. 780-M
• B299780LPMP0: Multi-parameter patient monitor. 780-L-pM-P
• B299780LPMO2P0: Multi-parameter patient monitor. 780-L-pMO2-P
• B299780LPMO20: Multi-parameter patient monitor. 780-L-pMO2
• B299780LPM0: Multi-parameter patient monitor. 780-L-pM
• B299780LP0: Multi-parameter patient monitor. 780-L-P
• B299780LIPMP0: Multi-parameter patient monitor. 780-L-I-pM-P