DEVICE: B.BRAUN (04046963845780)

Device Identifier (DI) Information

B.BRAUN
7210933
In Commercial Distribution
7210933
B.Braun Avitum AG
04046963845780
GS1

10
343689704 *Terms of Use
H.E.L.P. HEPARIN ADSORBER (US)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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
Apheresis kit A collection of sterile and disposable/consumable devices intended to be used to prepare for and perform (connect the patient) an apheresis treatment (e.g., immunoadsorption, plasmapheresis, plasma exchange) with an apheresis system. It typically consists of tubing, separation devices (e.g., adsorber, filter), and rinsing solutions for preparation of the extracorporeal circuit. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
MMY LIPOPROTEIN, LOW DENSITY, REMOVAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P940016 000
P940016 014
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

0b764886-e732-45c2-ac81-ed4033991f23
July 06, 2018
3
January 18, 2017
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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: 04046964249709 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)848-2066
rtd.us@bbraun.com
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