DEVICE: B.BRAUN (04046963716783)

Device Identifier (DI) Information

B.BRAUN
8713145U
In Commercial Distribution
8713145U
B. BRAUN MEDICAL INC.
04046963716783
GS1

1
002397347 *Terms of Use
SPACECOVER COMFORT - US VERSION
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Infusion pump management unit, mobile A mains electricity (AC-powered) mobile unit designed for the bedside organization, management, monitoring and electrical supply of many infusion pumps that are being used simultaneously to supply one patient. This device will be found in the intensive care unit (ICU) and helps achieve a high degree of organization of, e.g., the different infusion pumps, syringe pumps, the infusion sets and lines and the medication being infused.
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FDA Product Code

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Product Code Product Code Name
FRN Pump, infusion
LZH PUMP, INFUSION, ENTERAL
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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

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Storage and Handling
Storage Environment Temperature: between -20 and 55 Degrees Celsius
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

7cbf96a7-8595-4f4c-8c0c-a768b94925b4
October 05, 2018
3
January 18, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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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

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Yes
Yes
No
No
No CLOSE

Customer Contact

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