DEVICE: B.BRAUN (04046964310690)
Device Identifier (DI) Information
B.BRAUN
613405
Not in Commercial Distribution
613405
B BRAUN INTERVENTIONAL SYSTEMS, INC
613405
Not in Commercial Distribution
613405
B BRAUN INTERVENTIONAL SYSTEMS, INC
5F PICC DUAL 55 NITGOLD 80 CTD555-NG80
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? |
---|---|---|---|---|
36257 | Peripherally-inserted central venous catheter |
A thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K083873 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: ROOM TEMP |
Special Storage Condition, Specify: KEEP AWAY FROM SUNLIGHT. |
Special Storage Condition, Specify: KEEP DRY |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Length of guidewire : 80.000 CM |
Device Size Text, specify: Length of catheter : 55.000 CM |
Catheter Gauge: 5.00 French |
Device Record Status
95993f70-12ee-46b9-9ea5-4b732feca403
November 02, 2022
7
July 26, 2015
November 02, 2022
7
July 26, 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 |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
04046964310683
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