DEVICE: NA (04022495172532)

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Device Identifier (DI) Information

NA
622510
622510
B. BRAUN MEDICAL INC.
04022495172532
GS1
10
Inflator Syringe
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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
Catheter-balloon inflator, single-use A sterile device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon during a medical procedure. It typically consists of a dedicated syringe/plunger mechanism, a gauge or integral pressure transducer for monitoring pressure within the balloon, a locking mechanism, and a connecting tube. It may also be used to inflate the balloon of an inflatable balloon tamp or an endomicroscopy probe. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
DXT INJECTOR AND SYRINGE, ANGIOGRAPHIC
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Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
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

[?]
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

[?]
Unit of Use DI Number: 04022495172518 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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