Hummingbird® Parenchymal Catheter

FDA UDI

Class II (US FDA UDI)

by Irras USA

Identity

Trade Name: Hummingbird® Parenchymal Catheter FDA UDI
Generic Name: Intracerebral sensor catheter, short-term FDA UDI
Device Name: H110 Hummingbird Parenchymal Catheter Tray FDA UDI
Model / Reference: H110 FDA UDI
Description: H110 Hummingbird Parenchymal Catheter Tray FDA UDI

Identifiers

Catalog Number: H110 FDA UDI
Primary DI / UDI-DI: 00850013266036 FDA UDI
510(k) Number: K083378 FDA UDI
FDA Product Code: GWM FDA UDI
GMDN Term: Intracerebral sensor catheter, short-term FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1620 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 6 French FDA UDI

Category: Intracerebral sensor catheter, short-term

Hummingbird® Parenchymal Catheter by Irras USA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intracerebral sensor catheter, short-term.

NEUROVENT-TEMP — RAUMEDIC AG · Class II
AURA — Branchpoint & Aura Development LLC · Class II
NEUROVENT-IFD-S — RAUMEDIC AG · Class II
AURA — Branchpoint & Aura Development LLC · Class II
NEUROVENT-TEMP-IFD-R — RAUMEDIC AG · Class II
CODMAN® — Integra LifeSciences Production Corporation · Class II
NEUROVENT-P-TEMP — RAUMEDIC AG · Class II
Licox® — Integra LifeSciences Switzerland Sàrl · Class II

Cleared under the same submission

K083378 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Irras USA

Sources (1)

FDA UDI b3cbe6c9-1585-4ea2-bbe2-493708b17dac 37 fields · synced Jun 1, 2026