Identity
- Trade Name
- Jaeger FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- MasterScreen IOS FDA UDI
- Model / Reference
- 176400 FDA UDI
- Description
- MasterScreen IOS FDA UDI
Identifiers
- Catalog Number
- 176400 FDA UDI
- Primary DI / UDI-DI
- 04250892902777 FDA UDI
- 510(k) Number
- K122699 FDA UDI
- FDA Product Code
- BZC FDA UDI
- GMDN Term
- Pulmonary function analysis system, adult FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1880 FDA UDI
- Commercial Distribution
- Not 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
Jaeger by Jaeger Medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K122699 also covers:
- Jaeger — Jaeger Medical GmbH
- Jaeger — Jaeger Medical GmbH
- Jaeger — Jaeger Medical GmbH
- Jaeger — Jaeger Medical GmbH
- Jaeger — Jaeger Medical GmbH
- Jaeger — Jaeger Medical GmbH
- Jaeger — Jaeger Medical GmbH
- Jaeger — Jaeger Medical GmbH
- Jaeger — Jaeger Medical GmbH
- Jaeger — Jaeger Medical GmbH
- Jaeger — Jaeger Medical GmbH
- Jaeger — Jaeger Medical GmbH
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
- Jaeger Medical GmbH
Sources (1)
- FDA UDI 900491ea-280b-4d35-a3d4-9cf0ae5b6560 38 fields · synced Jun 1, 2026