Identity
- Trade Name
- Jaeger FDA UDI
- Generic Name
- Whole-body plethysmograph FDA UDI
- Device Name
- MasterScreen Body/Diff FDA UDI
- Model / Reference
- V-175420-13 FDA UDI
- Description
- MasterScreen Body/Diff FDA UDI
Identifiers
- Catalog Number
- V-175420-13 FDA UDI
- Primary DI / UDI-DI
- 04250892905174 FDA UDI
- 510(k) Number
- K122699 FDA UDI
- FDA Product Code
- BZC FDA UDI
- GMDN Term
- Whole-body plethysmograph 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
Yes
FDA UDI
Category: Whole-body plethysmograph
Jaeger by Jaeger Medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Whole-body plethysmograph.
- ReDS Pro System — SENSIBLE MEDICAL INNOVATIONS LTD · Class II
- ReDS Pro System — SENSIBLE MEDICAL INNOVATIONS LTD · Class II
- nSpire Health — NSPIRE HEALTH, INC. · Class II
- MGC Diagnostics — MEDICAL GRAPHICS CORP. · Class II
- ReDS Pro System — SENSIBLE MEDICAL INNOVATIONS LTD · Class II
- MGC Diagnostics — MEDICAL GRAPHICS CORP. · Class II
- KoKo, LLC — Koko, LLC · Class II
- nSpire Health — NSPIRE HEALTH, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jaeger Medical GmbH
Sources (1)
- FDA UDI 2c12b0de-cb38-4d77-afa7-04eaf7641f37 37 fields · synced May 31, 2026