Identity
- Trade Name
- Polytech Filter FDA UDI
- Generic Name
- Pulmonary function testing kit 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
- 100760WN 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
- B446100760WN1 FDA UDI
- FDA Product Code
- BZG FDA UDI
- GMDN Term
- Pulmonary function testing kit 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
Yes
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 — 38.8 Millimeter FDA UDI
Category: Pulmonary function testing kit
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 kit.
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- Pulmoguard — SDI DIAGNOSTICS, INC. · Class II
- KIT, MIR DISPOSABLE TURBINE & VBMAX30E — A-M Systems, Inc. · Class II
- All Flow — ALLIANCE TECH MEDICAL, INC. · Class II
- ABC Mouthpiece and Filter Kit — Aktina Corp.
- PFT Kit E, VBMax36E — A-M Systems, 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
- Polytechnic Resources, Inc.
Sources (1)
- FDA UDI 8679c5f5-7b3e-4498-b8f1-422c4039143a 34 fields · synced May 30, 2026