DEVICE: H.E.L.P.® (04046964699467)

Device Identifier (DI) Information

H.E.L.P.®
7061192
In Commercial Distribution
7061192
B.Braun Avitum AG
04046964699467
GS1

80
343689704 *Terms of Use
HELP HEPARIN 400,000 IU V 50/40ML US
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58091 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.
Active false
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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 016
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 4 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Volume : 40.000 ML
Device Size Text, specify: Concentration (IU/ml) : 10000.000 IE3
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Device Record Status

fb08f074-0693-4419-a1fa-aac607d9c9ee
September 12, 2019
6
March 09, 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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 04046955348367 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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