DEVICE: Hummingbird® Parenchymal Catheter (00850013266036)

Device Identifier (DI) Information

Hummingbird® Parenchymal Catheter
H110
In Commercial Distribution
H110
Irras USA, Inc.
00850013266036
GS1

1
056999617 *Terms of Use
H110 Hummingbird Parenchymal Catheter Tray
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Device Characteristics

MR Conditional
No
No
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?
61398 Intracerebral sensor catheter, short-term
A flexible tube with a sensor at the distal end intended to be surgically inserted through the skull for short-term (= 30 days) access to the ventricular and/or parenchymal areas of the brain to measure intracranial parameters [e.g., intracranial pressure (ICP), temperature, partial pressure of oxygen (pO2)]; it may in addition be intended for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents, radioisotopes). It may include accessory devices intended to facilitate catheter introduction, stabilization, and/or fluid collection/infusion (e.g., stylet, bolts, drills, drainage/infusion port/reservoir). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GWM Device, Monitoring, Intracranial Pressure
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K083378 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 6 French
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Device Record Status

b3cbe6c9-1585-4ea2-bbe2-493708b17dac
June 11, 2024
4
October 10, 2019
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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
10850013266033 1 00850013266036 In Commercial Distribution Box
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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

[?]
800-213-4604
info@irras.com
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