DEVICE: Prontosan® (04046964295843)

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Device Identifier (DI) Information

Prontosan®
400443
400443
B. BRAUN MEDICAL INC.
04046964295843
GS1
10
PRONTOSAN WOUND IRRIGATION SOLUT. 1000ML
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Sterile wound irrigation solution, antimicrobial A sterile solution that includes an antimicrobial agent [e.g., polyhexanide (PHMB)] intended to be used to irrigate, clean/moisten, and decontaminate a wound or burn to aid in autolytic debridement, and to moisten/lubricate a wound dressing. It may be used for acute or chronic wounds, including first or second degree burns. After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
FRO Dressing, wound, drug
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: DO NOT REFRIGERATE OR FREEZE.
Special Storage Condition, Specify: AVOID EXCESSIVE HEAT.
Special Storage Condition, Specify: STORE AT ROOM TEMPERATURE.
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Volume : 1000.000 ML
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Device Status

In Commercial Distribution
September 23, 2016

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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

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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: 04046964295836 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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