DEVICE: CELSITE (04046963595104)

Device Identifier (DI) Information

CELSITE
5437025
Not in Commercial Distribution
5437025
B BRAUN INTERVENTIONAL SYSTEMS, INC
04046963595104
GS1
December 10, 2021
1
784259751 *Terms of Use
CELSITE ST501G ST SET SIL 10F 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© 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?
61494 Vascular port/catheter
A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.
Active true
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FDA Product Code

[?]
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

[?]
Storage and Handling
Special Storage Condition, Specify: KEEP DRY
Special Storage Condition, Specify: Store at room temp
Special Storage Condition, Specify: Avoid extreme temperature
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify:
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Septum Diameter : 12.000 MM
Catheter Gauge: 10.00 French
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Device Record Status

4fb080a3-3f6b-433b-b9ea-699b847a8461
September 07, 2023
6
July 29, 2015
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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: 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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