DEVICE: B.BRAUN (04046964366383)

Device Identifier (DI) Information

B.BRAUN
PP001922
In Commercial Distribution
PP001922
B. BRAUN MEDICAL INC.
04046964366383
GS1

10
002397347 *Terms of Use
Bloodline Extension Set (3 ft tubing)
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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
Haemodialysis tubing set, single-use A collection of sterile items intended for the administration of haemodialysis. It will typically consist of a collection of tubing segments and, e.g., connectors or clamps, required to transport blood or other fluids from a patient's vascular access device to the appropriate dialyser (haemodialyser) unit for processing. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FJK SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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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

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

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Size Type Text
No Device Sizes
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Device Record Status

2f1fc8e2-e7e4-45ed-ae34-0e76c46c13e2
March 29, 2018
2
August 09, 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

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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: 04046964366376 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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