Identity
- Trade Name
- Astra Spirometer FDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- Spirometer FDA UDI
- Model / Reference
- 300 FDA UDI
- Description
- Spirometer FDA UDI
Identifiers
- Catalog Number
- 29-5301-050 FDA UDI
- Primary DI / UDI-DI
- B279S295301050 FDA UDI
- 510(k) Number
- K061571 FDA UDI
- FDA Product Code
- BZG FDA UDI
- GMDN Term
- Diagnostic spirometer, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1840 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
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
The Astra Spirometer is a professional-grade, hand-held diagnostic device designed for the evaluation of basic pulmonary function in patients with chronic respiratory disorders. Accurately measuring vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and pulse oximetry, this device aids in diagnosis and monitoring of conditions such as asthma, emphysema, and bronchitis.
Cleared under the same submission
K061571 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
- Sdi Diagnostics, Inc.
Sources (1)
- FDA UDI a78e5ad2-73eb-41d6-9bdb-3b51ca57b4e5 36 fields · synced Jul 31, 2026