Identity
- Trade Name
- Burn Navigator FDA UDI
- Generic Name
- Clinical information system web-based application software FDA UDI
- Device Name
- Burn Navigator H2 Transport FDA UDI
- Model / Reference
- H2 Transport FDA UDI
- Description
- Burn Navigator H2 Transport FDA UDI
Identifiers
- Catalog Number
- 1125 FDA UDI
- Primary DI / UDI-DI
- B2551125 FDA UDI
- 510(k) Number
- K121659 FDA UDI
- FDA Product Code
- PDT FDA UDI
- GMDN Term
- Clinical information system web-based application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1890 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
No
FDA UDI
MR Unsafe FDA UDI
Category: Clinical information system web-based application software
Burn Navigator by Arcos, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Clinical information system web-based application software.
- PACS Scan Mobile — HYLAND LLC · Class I
- Burn Navigator — Arcos, Inc. · Class II
- Burn Navigator — Arcos, Inc. · Class II
Cleared under the same submission
K121659 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
- Arcos, Inc.
Sources (1)
- FDA UDI a9618ea6-c1ed-4af0-a093-775ed8289144 36 fields · synced May 30, 2026