DEVICE: Irrigation Set (04046964175794)

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Device Identifier (DI) Information

Irrigation Set
313003
313003
B. BRAUN MEDICAL INC.
04046964175794
GS1
10
Two-Bag Irrigation Set, Two Non-vented Spikes
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
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
Surgical irrigation tubing set, single-use A collection of sterile, flexible, single-bore, external tubing intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline solution) from its source (e.g., gravity feed bag, feed pump) to the surgical intervention site; it is not intended to navigate through an anatomical lumen. The tubing typically includes associated items such as clamps, filters, spikes, and connectors; it may include an integrated manual pump (e.g., a squeeze bulb) to assist in the channelling between the irrigation source and the point of application. Some types may have dual tubing to help expedite gastric lavage procedures. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LJH System, irrigation, urological
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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 23, 2016

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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: 04046964175787 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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