Flexport 91439B

GUDID 10841522106378

EDWARDS VIG

SPACELABS HEALTHCARE (WASHINGTON), INC

Patient monitoring system module, interfacing

• Primary Device ID: 10841522106378
• NIH Device Record Key: 70cfadef-741b-4e17-b404-ba98164ae517
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexport
• Version Model Number: 91439B
• Catalog Number: 91439B
• Company DUNS: 145581588
• Company Name: SPACELABS HEALTHCARE (WASHINGTON), 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 75 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522106378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K903702

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-08-18
• Device Publish Date: 2016-11-10

On-Brand Devices [Flexport]

• 10841522105098: T/A,FLEXPORT,HAMILTON,VENT,INTRFC
• 10841522105180: UNIVERSAL FLEXPORT
• 10841522105159: T/A,FLEXPORT,DRAGER EVITA 4 VENT
• 10841522105142: T/A,FLEXPORT,PB840,VENTILATOR INTERFACE
• 10841522105135: T/A,FLEXPORT,DRAGER EVITA 2 & EVITA 2 DURA
• 10841522105128: T/A,FLEXPORT,DRAGER BABYLOG 8000
• 10841522105104: T/A,FLEXPORT,DRAGER,VENT,INTRFC
• 10841522106408: FLEXPORT-2,DRAEGER,91443C
• 10841522106392: FLEXPORT 2,MAQUET FLOW-I,91443B
• 10841522106378: EDWARDS VIG
• 10841522106361: FLEXPORT 2,PICCO PULSION,91439A
• 10841522106347: FLEXPORT-2 INTERFACE,FP 2,GE ENGSTROM CS,91436E
• 10841522106330: FLEXPORT 2 INTERFACE,GE AVANCE,91436D
• 10841522106323: FLEXPORT 2 INTERFACE,VIASYS,91436C
• 10841522106316: FLEXPORT 2 INTERFACE, SERVO I,91436B
• 10841522100062: FLEXPORT,PULSION PICCO,INTERFACE,90439