VitalStream CT-VS-SM, CT-VS-CM, CT-VS-HM

GUDID 00864609000317

Wireless Vital Signs Monitor

CARETAKER MEDICAL, LLC

General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor

• Primary Device ID: 00864609000317
• NIH Device Record Key: 1916b7dc-ee03-4f23-947e-20ded8005083
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitalStream
• Version Model Number: CT5
• Catalog Number: CT-VS-SM, CT-VS-CM, CT-VS-HM
• Company DUNS: 079403856
• Company Name: CARETAKER MEDICAL, LLC
• 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

Customer Support Contacts

• Phone: +1(434)978-7000
• Email: paul@caretakermedical.net
• Phone: +1(434)978-7000
• Email: paul@caretakermedical.net
• Phone: +1(434)978-7000
• Email: paul@caretakermedical.net
• Phone: +1(434)978-7000
• Email: paul@caretakermedical.net
• Phone: +1(434)978-7000
• Email: paul@caretakermedical.net
• Phone: +1(434)978-7000
• Email: paul@caretakermedical.net
• Phone: +1(434)978-7000
• Email: paul@caretakermedical.net
• Phone: +1(434)978-7000
• Email: paul@caretakermedical.net
• Phone: +1(434)978-7000
• Email: paul@caretakermedical.net
• Phone: +1(434)978-7000
• Email: paul@caretakermedical.net

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864609000317 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-14
• Device Publish Date: 2022-04-06

Devices Manufactured by CARETAKER MEDICAL, LLC

• 00864609000317 - VitalStream: 2022-04-14Wireless Vital Signs Monitor
• 00864609000317 - VitalStream: 2022-04-14 Wireless Vital Signs Monitor
• 00864609000300 - Caretaker4: 2020-01-07 Wireless Vital Signs Monitor
• 08646090003013 - Caretaker4: 2019-07-09 Wireless Vital Signs Monitor