Identity
- Trade Name
- Polytech Filter FDA UDI
- Generic Name
- Pulmonary function testing filter/mouthpiece FDA UDI
- Device Name
- Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for single patient use only. FDA UDI
- Model / Reference
- 756EL FDA UDI
- Description
- Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for single patient use only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B446756EL1 FDA UDI
- 510(k) Number
- K042758 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
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
Dimensions & Sizes
- Size
- Outer Diameter — 48.6 Millimeter FDA UDI
Category: Pulmonary function testing filter/mouthpiece
Polytech Filter by Polytechnic Resources, 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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- Disposable Flow Transducer — Medikro Oy · Class IIa
- Pulmoguard — SDI DIAGNOSTICS, INC. · Class II
- Pulmoguard — SDI DIAGNOSTICS, INC. · Class II
- SP-MIX 2 - bombola da 11 L — Air Liquide Italia Gas e Servizi S.r.l. · Class IIa
Cleared under the same submission
K042758 also covers:
- MCG Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
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
- Polytechnic Resources, Inc.
Sources (1)
- FDA UDI f972a529-ce4e-4b59-9995-a0b21af71c23 35 fields · synced May 30, 2026