Identity
- Trade Name
- BodyBox FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- Body plethysmograph with DLCO He Dilution. Inspiratory bag. XL Size. Pulmonary function testing, measuring lung volumes and airway resistance by spirometry and body plethysmography. FDA UDI
- Model / Reference
- DLCO He IB Si XL FDA UDI
- Description
- Body plethysmograph with DLCO He Dilution. Inspiratory bag. XL Size. Pulmonary function testing, measuring lung volumes and airway resistance by spirometry and body plethysmography. FDA UDI
Identifiers
- Catalog Number
- BB-00-02 FDA UDI
- Primary DI / UDI-DI
- 05407003160024 FDA UDI
- 510(k) Number
- K022636 FDA UDI
- FDA Product Code
- JEH FDA UDI
- GMDN Term
- Pulmonary function analysis system, adult FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1760 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: Pulmonary function analysis system, adult
BodyBox by Medi Soft SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K022636 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
- Medi Soft SA
Sources (1)
- FDA UDI 959d9525-3379-4c60-a06e-5751e1c7d838 37 fields · synced Jun 8, 2026