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Pulmo-Protect Lung Function Filter With Integrated Mouthpiece
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE FDA UDI
- Generic Name
- Pulmonary function testing filter/mouthpiece FDA UDI
- Device Name
- PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE FDA UDI
- Model / Reference
- 1691005 FDA UDI
- Description
- PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05030267160631 FDA UDI
- 510(k) Number
- K013123 FDA UDI
- FDA Product Code
- BZG FDA UDI
- GMDN Term
- Pulmonary function testing filter/mouthpiece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1840 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulmonary function testing filter/mouthpiece
Pulmo-Protect Lung Function Filter With Integrated Mouthpiece by Intersurgical Incorporated — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Pulmonary function testing filter/mouthpiece.
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- Pulmoguard — SDI DIAGNOSTICS, INC. · Class II
- Polytech Filter — POLYTECHNIC RESOURCES, INC. · Class II
- Disposable Flow Transducer — Medikro Oy · Class IIa
- Pulmoguard — SDI DIAGNOSTICS, INC. · Class II
- Polytech Filter — POLYTECHNIC RESOURCES, INC. · Class II
Cleared under the same submission
K013123 also covers:
- Pulmonary Function Filter — Engineered Medical Systems, LLC
- PULMO-PROTECT BREATHING FILTER WITH FLEXIBLE MOUTHPIECE AND NOSE CLIP — Intersurgical Incorporated
- PULMO-PROTECT BREATHING FILTER WITH FLEXIBLE MOUTHPIECE AND NOSE CLIP — Intersurgical Incorporated
- PULMO-PROTECT LUNG FUNCTION FILTER — Intersurgical Incorporated
- PULMO-PROTECT LUNG FUNCTION FILTER — Intersurgical Incorporated
- PULMO-PROTECT LUNG FUNCTION FILTER — Intersurgical Incorporated
- PULMO-PROTECT LUNG FUNCTION FILTER — Intersurgical Incorporated
- PULMO-PROTECT LUNG FUNCTION FILTER — Intersurgical Incorporated
- PULMO-PROTECT LUNG FUNCTION FILTER — Intersurgical Incorporated
- PULMO-PROTECT LUNG FUNCTION FILTER WITH FLEXIBLE MOUTHPIECE AND NOSE CLIP — Intersurgical Incorporated
- PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE — Intersurgical Incorporated
- PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECE — Intersurgical Incorporated
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
- Intersurgical Incorporated
Sources (1)
- FDA UDI 9f0408d3-11ee-4aa0-809f-80c204913965 35 fields · synced May 31, 2026