DEVICE: CELSITE (04046963594954)

Device Identifier (DI) Information

CELSITE
5433750
In Commercial Distribution
5433750
B BRAUN INTERVENTIONAL SYSTEMS, INC
04046963594954
GS1

1
784259751 *Terms of Use
CELSITE ST305 SM SET SIL 6,5F IV USA
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Infusion/injection port, implantable A sterile metallic and/or non-metallic device intended to be implanted subcutaneously in a patient for the short- or long-term delivery of fluids or medications to the vascular system or other anatomical region. The device consists of a housing with a self-sealing septum and a catheter connection mechanism. The device may be implanted in various anatomical locations. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LJT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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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

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Storage and Handling
Special Storage Condition, Specify: ROOM TEMP AVOID FREEZE & HEAT
Special Storage Condition, Specify: KEEP DRY
Special Storage Condition, Specify: KEEP AWAY FROM SUNLIGHT.
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Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 6.50 French
Device Size Text, specify: Septum Diameter : 9.500 MM
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Device Record Status

bd8d23a1-9979-4a19-9e33-83838da87f6a
June 15, 2018
3
July 29, 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

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found 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(877)836-2228
GUDID.BBMUS_Service@bbraun.com
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