Identity
- Trade Name
- Pulmoguard FDA UDI
- Generic Name
- Pulmonary function testing filter/mouthpiece FDA UDI
- Device Name
- Pulmonary Function Test Filter FDA UDI
- Model / Reference
- S FDA UDI
- Description
- Pulmonary Function Test Filter FDA UDI
Identifiers
- Catalog Number
- 29-3105-200 FDA UDI
- Primary DI / UDI-DI
- B279S293105200 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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- Polytech Filter — POLYTECHNIC RESOURCES, INC. · Class II
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 fad432bb-aa02-4c68-a32c-e961aca32eda 34 fields · synced May 30, 2026