DEVICE: B.BRAUN (04046964310546)

Device Identifier (DI) Information

B.BRAUN
613400
Not in Commercial Distribution
613400
B BRAUN INTERVENTIONAL SYSTEMS, INC
04046964310546
GS1
July 10, 2016
5
784259751 *Terms of Use
4F PICC SINGLE 50 NITGOLD 80 CTS450-NG80
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Peripherally-inserted central venous catheter A sterile, thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LJS Catheter,intravascular,therapeutic,long-term greater than 30 days
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FDA Premarket Submission

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

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: KEEP AWAY FROM SUNLIGHT.
Special Storage Condition, Specify: KEEP DRY
Special Storage Condition, Specify: ROOM TEMP
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Length of catheter : 50.000 CM
Device Size Text, specify: Length of guidewire : 80.000 CM
Catheter Gauge: 4.00 French
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Device Record Status

5840ba61-46ff-4035-a5de-f7e98343bfd9
March 29, 2018
2
July 22, 2015
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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

[?]
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: 04046964310522 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(877)836-2228
GUDID.BBMUS_Service@bbraun.com
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