Identity
- Trade Name
- CAMINO® FDA UDI
- Generic Name
- Intracranial pressure monitor FDA UDI
- Device Name
- Intracranial Pressure and Temperature Monitor FDA UDI
- Model / Reference
- CAM02 FDA UDI
- Description
- Intracranial Pressure and Temperature Monitor FDA UDI
Identifiers
- Catalog Number
- CAM02 FDA UDI
- Primary DI / UDI-DI
- 00382830049023 FDA UDI
- 510(k) Number
- K121573 FDA UDI
- FDA Product Code
- GWM FDA UDI
- GMDN Term
- Intracranial pressure monitor 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intracranial pressure monitor
Camino® by Natus Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K121573 also covers:
- Integra® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Integra® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Integra® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CAMINO® — Natus Medical Incorporated
- CAMINO® — Natus Medical Incorporated
- CAMINO® — Natus Medical Incorporated
- CAMINO® — Natus Medical Incorporated
- CAMINO® — Natus Medical Incorporated
- Natus — Natus Medical Incorporated
- Natus — Natus Medical Incorporated
- Natus — Natus Medical Incorporated
- Natus — Natus Medical Incorporated
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Natus Medical Incorporated
Sources (1)
- FDA UDI 55154b00-a64a-4bfa-85e6-36fed201d3b9 37 fields · synced May 30, 2026