DEVICE: GAV® (04041906126803)

Device Identifier (DI) Information

GAV®
FV328T
Not in Commercial Distribution
FV328T
Christoph Miethke GmbH & Co. KG
04041906126803
GS1
March 11, 2021
1
343189676 *Terms of Use
GAV SYSTEM W.PRECHAMBER 5/30
CLOSE

Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
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?
61123 Ventriculo-peritoneal/atrial shunt
An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the brain ventricles to either the peritoneal cavity or the heart right atrium (i.e., dual-capability), where it can be absorbed into the body, as a treatment for increased intracranial pressure (e.g., caused by hydrocephalus). It consists of: 1) an intracerebral ventricular catheter through which CSF flows; 2) a mechanical shunt valve that typically opens at a pre-set pressure; and 3) a peritoneal/atrial catheter that channels the CSF to the peritoneal cavity or right atrium; some types have a port/reservoir for hypodermic sampling/infusion. Disposable devices associated with implantation may be included.
Active true
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
JXG Shunt, central nervous system and components
CLOSE

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
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Pressure rating horiz. (cmH2O) : 5.000 CWS
Device Size Text, specify: Pressure rating vert. (cmH2O) : 30.000 CWS
CLOSE

Device Record Status

2f1b9ed1-5b33-446d-bba7-8eb817c56d38
April 07, 2021
4
September 24, 2015
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)282-9000
GUDID.BBMUS_Service@bbraun.com
CLOSE