DEVICE: B.BRAUN (04046963716769)

Notice: Any discrepancies with this record compared to the label?
If so, send a picture of the label to GUDIDSupport@fda.hhs.gov.

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
B.BRAUN
8713140U
In Commercial Distribution
8713140U
B. BRAUN MEDICAL INC.
04046963716769
GS1

1
002397347 *Terms of Use
SpaceStation
CLOSE

Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FRN Pump, infusion
LZH PUMP, INFUSION, ENTERAL
CLOSE

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
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Special Storage Condition, Specify:
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Fragile, handle with care
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: between -20 and 55 Degrees Celsius
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
8f3b4853-7dc2-4541-be7f-0eed66ae73ab
June 30, 2025
10
September 23, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
No
No
No CLOSE

Customer Contact

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