DEVICE: Spacelabs Healthcare (10841522125560)
Device Identifier (DI) Information
Spacelabs Healthcare
BLSIRIUS
In Commercial Distribution
FR101029
SPACELABS HEALTHCARE (WASHINGTON), INC
BLSIRIUS
In Commercial Distribution
FR101029
SPACELABS HEALTHCARE (WASHINGTON), INC
PATIENT FLOW SENSOR AND TUBING KIT (2.0M)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
47769 | Anaesthesia unit, mobile |
A stand-alone assembly of devices on wheels for mobility designed to continuously or intermittently administer a mixture of gases [e.g., oxygen (O2), ambient/medical air, nitrous oxide (N2O), anaesthetic agents] to provide a patient with an appropriate level of anaesthesia for a surgical procedure. Also known as an anaesthesia machine, it may include an oxygen concentrator or function with mounted medical gas cylinders, and typically has mechanical gas-delivery devices (e.g., flowmeters and vaporizers). It may incorporate a powered or manual anaesthesia ventilator, a patient breathing circuit, and gas monitoring devices; patient monitors are typically separately mounted (not integral).
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CBK | VENTILATOR, CONTINUOUS, FACILITY USE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
465541f0-203a-4c32-974d-35223dfa8428
October 15, 2018
1
September 12, 2018
October 15, 2018
1
September 12, 2018
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
[?]
No Customer Contact currently defined