Identity
- Trade Name
- SPIROTRAC FDA UDI
- Generic Name
- Cardiopulmonary parameter spot-check measurement software FDA UDI
- Device Name
- 7000 SPIROTRAC FDA UDI
- Model / Reference
- 7000 FDA UDI
- Description
- 7000 SPIROTRAC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 65099169688003 FDA UDI
- 510(k) Number
- K141546 FDA UDI
- FDA Product Code
- BZG FDA UDI
- GMDN Term
- Cardiopulmonary parameter spot-check measurement software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1840 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiopulmonary parameter spot-check measurement software
Spirotrac by Vitalograph Ireland, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary parameter spot-check measurement software.
- ers2 Basic Software — ergoline GmbH · Class II
Cleared under the same submission
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
- Vitalograph Ireland, Ltd.
Sources (1)
- FDA UDI 57d7f0d5-d820-4e4e-a541-d46c0fdebcdd 34 fields · synced May 30, 2026