Identity
- Trade Name
- COSMED FDA UDI
- Generic Name
- Cardiopulmonary stress exercise monitoring system FDA UDI
- Model / Reference
- K5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18052400180485 FDA UDI
- 510(k) Number
- K162515 FDA UDI
- FDA Product Code
- BZC FDA UDI
- GMDN Term
- Cardiopulmonary stress exercise monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1880 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
Category: Cardiopulmonary stress exercise monitoring system
Cosmed by C O S M E D Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiopulmonary stress exercise monitoring system.
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- Vyaire — Jaeger Medical GmbH · Class II
- Innocor — Innovision ApS · Class II
- Innocor — Innovision ApS · Class II
- Vyaire — Jaeger Medical GmbH · Class II
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
- C O S M E D Srl
Sources (1)
- FDA UDI 48709928-08e6-427c-b157-f1484a2c5279 34 fields · synced Jun 8, 2026