Identity
- Trade Name
- Hummingbird® SynergyDuo FDA UDI
- Generic Name
- Intracerebral sensor catheter, short-term FDA UDI
- Device Name
- H610 Hummingbird SynergyDuo Ventricular Catheter Tray FDA UDI
- Model / Reference
- H610 FDA UDI
- Description
- H610 Hummingbird SynergyDuo Ventricular Catheter Tray FDA UDI
Identifiers
- Catalog Number
- H610 FDA UDI
- Primary DI / UDI-DI
- 00850013266029 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 8.5 French FDA UDI
Category: Intracerebral sensor catheter, short-term
Hummingbird® SynergyDuo 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 fffef5ba-2b67-449b-b2aa-7aae3dba1be2 37 fields · synced May 30, 2026