Identity
- Trade Name
- Virtuox FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- VPOD Capox, Handheld Capnography and Pulse Oximetry Device FDA UDI
- Model / Reference
- 1300 FDA UDI
- Description
- VPOD Capox, Handheld Capnography and Pulse Oximetry Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817698020032 FDA UDI
- 510(k) Number
- K170820 FDA UDI
- FDA Product Code
- DQA FDA UDICCK FDA UDI
- GMDN Term
- Pulse oximeter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 FDA UDI868.1400 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
No
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
Category: Pulse oximeterCarbon dioxide monitor
Virtuox by Healthcare Logistics Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carbon dioxide monitor.
- cap-ONE — Nihon Kohden Corp. · Class I
- CD3A — AEI TECHNOLOGIES INC. · Class II
- cap-ONE — Nihon Kohden Corp. · Class II
- BCI — ICU MEDICAL, INC. · Class II
- cap-ONE — Nihon Kohden Corp. · Class II
- cap-ONE — NIHON KOHDEN AMERICA, INC. · Class II
- cap-ONE — Nihon Kohden Corp. · Class I
- Nonin — Nonin Medical, Inc. · Class II
Cleared under the same submission
K170820 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
- Healthcare Logistics Systems
Sources (1)
- FDA UDI b4ab0bac-0c83-4c34-8b96-b0385b0baef8 35 fields · synced May 30, 2026