DEVICE: SPACE (04046963418373)

Device Identifier (DI) Information

SPACE
8713152
In Commercial Distribution
8713152
B. BRAUN MEDICAL INC.
04046963418373
GS1

1
002397347 *Terms of Use
SpaceStation MRI
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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
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FDA Product Code

[?]
Product Code Product Code Name
FRN Pump, infusion
MRZ ACCESSORIES, PUMP, INFUSION
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

477cfef7-4c3c-4e8b-a824-1c055ace740e
June 30, 2025
5
August 21, 2020
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)227-2862
BBMUS_Service.EmailOrders@bbraun.com
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