Identity
- Trade Name
- Pulmoguard FDA UDI
- Generic Name
- Pulmonary function testing filter/mouthpiece FDA UDI
- Device Name
- Pulmonary function bacterial filter FDA UDI
- Model / Reference
- V FDA UDI
- Description
- Pulmonary function bacterial filter FDA UDI
Identifiers
- Catalog Number
- F0609-300 FDA UDI
- Primary DI / UDI-DI
- B279F0609300 FDA UDI
- 510(k) Number
- K934509 FDA UDI
- FDA Product Code
- CAH FDA UDI
- GMDN Term
- Pulmonary function testing filter/mouthpiece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5260 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulmonary function testing filter/mouthpiece
Pulmoguard by Sdi Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pulmonary function testing filter/mouthpiece.
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- Polytech Filter — POLYTECHNIC RESOURCES, INC. · Class II
- Disposable Flow Transducer — Medikro Oy · Class IIa
- Polytech Filter — POLYTECHNIC RESOURCES, INC. · Class II
- SP-MIX 2 - bombola da 11 L — Air Liquide Italia Gas e Servizi S.r.l. · Class IIa
- BlockAide Pulmonary Function Filter — WESTMED, INC. · Class II
- Polytech Filter — POLYTECHNIC RESOURCES, INC. · Class II
Cleared under the same submission
K934509 also covers:
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
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 3dadad30-2475-4a9b-bd44-c9c88800ee8a 35 fields · synced Jun 1, 2026