SENTINEL 040-1725-00

GUDID 10841522123207

SENTINEL 10 TEST SYSTEM, RDT

SPACELABS HEALTHCARE (WASHINGTON), INC

Cardiology information system application software

• Primary Device ID: 10841522123207
• NIH Device Record Key: cad1be11-ee1c-43a7-92ee-ca6584484fd9
• Commercial Distribution Discontinuation: 2024-04-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SENTINEL
• Version Model Number: 98200
• Catalog Number: 040-1725-00
• 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: true
• Serial Number: false
• 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 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522123207 [Primary]

FDA Product Code

• DXH: TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE

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: 2024-05-08
• Device Publish Date: 2017-08-15

On-Brand Devices [SENTINEL]

• 10841522104565: DISPLAY,19" LOW COST XPREZZON,94267
• 10841522123214: SENTINEL 10 TEST SYSTEM HL7/DICOM
• 10841522129315: SENTINEL 11 / PATHFINDER SL KIT FR
• 10841522129285: SENTINEL 11 STANDALONE TEST SYSTEM
• 10841522129551: UPGRADE, SENTINEL 10.5 TO 11.5 OR HIGHER
• 10841522129414: SENTINEL 11 RDT TEST SYSTEM
• 10841522129308: SENTINEL 11 HL7 TEST SYSTEM
• 10841522129292: SENTINEL 11 NETWORKED TEST SYSTEM
• 10841522104558: 94267
• 10841522125751: SENTINEL SOFTWARE V11
• 10841522130922: SENTINEL 11 HL7 TEST SYSTEM
• 10841522129384: SENTINEL 11 / PATHFINDER SL KIT NL
• 10841522129339: SENTINEL 11 / PATHFINDER SL KIT IT
• 10841522123207: SENTINEL 10 TEST SYSTEM, RDT
• 10841522123191: SENTINEL 10 TEST SYSTEM, NETWORKED (ENG)
• 10841522123184: SENTINEL 10 TEST SYSTEM, STAND ALONE (ENG)
• 10841522100710: SENTINEL