Tunneling KIT CH12

GUDID 04057834090468

RAUMEDIC AG

Subcutaneous tunneller, single-use
Primary Device ID04057834090468
NIH Device Record Keyc2757e3b-5847-4572-b988-79469b8710c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTunneling KIT CH12
Version Model Number090727-001
Company DUNS332785323
Company NameRAUMEDIC AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18886470070
Emailneuromonitoring@raumedic.com
Phone+18886470070
Emailneuromonitoring@raumedic.com
Phone+18886470070
Emailneuromonitoring@raumedic.com
Phone+18886470070
Emailneuromonitoring@raumedic.com
Phone+18886470070
Emailneuromonitoring@raumedic.com
Phone+18886470070
Emailneuromonitoring@raumedic.com
Phone+18886470070
Emailneuromonitoring@raumedic.com
Phone+18886470070
Emailneuromonitoring@raumedic.com
Phone+18886470070
Emailneuromonitoring@raumedic.com
Phone+18886470070
Emailneuromonitoring@raumedic.com
Phone+18886470070
Emailneuromonitoring@raumedic.com
Phone+18886470070
Emailneuromonitoring@raumedic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104057834090468 [Primary]

FDA Product Code

GWMDevice, monitoring, intracranial pressure

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-16
Device Publish Date2025-12-08

Devices Manufactured by RAUMEDIC AG

04057834023541 - Tunneling KIT CH82025-12-16
04057834090468 - Tunneling KIT CH122025-12-16
04057834090468 - Tunneling KIT CH122025-12-16
04057834026115 - NEUROVENT-P2025-12-15
04057834082845 - NEUROVENT2025-12-15
04057834082876 - NEUROVENT-IFD-S2025-12-15
04057834082883 - NEUROVENT-IFD-R2025-12-15
04057834082906 - NEUROVENT-TEMP-IFD-S2025-12-15
04057834082913 - NEUROVENT-TEMP-IFD-R2025-12-15

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