DEVICE: CELSITE (04046963594756)
Device Identifier (DI) Information
CELSITE
5430145
Not in Commercial Distribution
5430145
B BRAUN INTERVENTIONAL SYSTEMS, INC
5430145
Not in Commercial Distribution
5430145
B BRAUN INTERVENTIONAL SYSTEMS, INC
CELSITE STR201L ST SET SIL 8,5F R IV USA
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. 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.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LJT | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: KEEP DRY |
Special Storage Condition, Specify: Avoid extreme temperature |
Special Storage Condition, Specify: Keep away from sunlight |
Special Storage Condition, Specify: Store at room temp |
Special Storage Condition, Specify: |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Septum Diameter : 12.500 MM |
Catheter Gauge: 8.50 French |
Device Record Status
c790734b-6d40-485c-a0ca-49effe9df327
September 07, 2023
6
July 29, 2015
September 07, 2023
6
July 29, 2015
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(877)836-2228
GUDID.BBMUS_Service@bbraun.com
GUDID.BBMUS_Service@bbraun.com