DEVICE: VitalStream (00864609000317)
Device Identifier (DI) Information
VitalStream
CT5
In Commercial Distribution
CT-VS-SM, CT-VS-CM, CT-VS-HM
CARETAKER MEDICAL, LLC
CT5
In Commercial Distribution
CT-VS-SM, CT-VS-CM, CT-VS-HM
CARETAKER MEDICAL, LLC
Wireless Vital Signs Monitor
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
33586 | General-purpose multi-parameter bedside monitor |
An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DXN | System, measurement, blood-pressure, non-invasive |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -25 and 70 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
1916b7dc-ee03-4f23-947e-20ded8005083
April 14, 2022
1
April 06, 2022
April 14, 2022
1
April 06, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(434)978-7000
102
paul@caretakermedical.net
paul@caretakermedical.net