DEVICE: SPACE (04046963418373)
Device Identifier (DI) Information
Device Characteristics
MR Safe | |
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? |
---|---|---|---|---|
36179 | Multiple infusion pump management station |
An electrically-powered unit designed for the bedside organization, management, operating control of infusion parameters, pump performance monitoring, and electrical supply of multiple infusion and/or syringe pumps that are being used simultaneously or sequentially. It typically consists of a tower rack with slots for the pumps, electrical sockets, infusion controls (e.g., automated relay changeovers between pumps), and alarms; some types have a user interface software/display, magnetic shielding properties for use during resonance imaging (MRI) procedures, and may be capable of detecting magnetic flux density to monitor pump performance during MRI.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FRN | Pump, infusion |
MRZ | ACCESSORIES, PUMP, INFUSION |
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 Humidity: between 20 and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify: Keep away from sunlight |
Special Storage Condition, Specify: |
Storage Environment Temperature: between -20 and 55 Degrees Celsius |
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Handling Environment Temperature: between 5 and 40 Degrees Celsius |
Special Storage Condition, Specify: Keep dry |
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Special Storage Condition, Specify: Fragile, handle with care |
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
477cfef7-4c3c-4e8b-a824-1c055ace740e
June 30, 2025
5
August 21, 2020
June 30, 2025
5
August 21, 2020
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(800)227-2862
BBMUS_Service.EmailOrders@bbraun.com
BBMUS_Service.EmailOrders@bbraun.com