Identity
- Trade Name
- Polytech Mouthpiece FDA UDI
- Generic Name
- Pulmonary function testing filter/mouthpiece FDA UDI
- Device Name
- A device designed to be inserted into a patient's mouth to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that provides an appropriate gastight seal (i.e., with a patient's lips) and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector). This is a single-use device. FDA UDI
- Model / Reference
- N100754 FDA UDI
- Description
- A device designed to be inserted into a patient's mouth to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that provides an appropriate gastight seal (i.e., with a patient's lips) and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector). This is a single-use device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B446N1007541 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulmonary function testing filter/mouthpiece
Polytech Mouthpiece by Polytechnic Resources, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary function testing filter/mouthpiece.
- SP-MIX 1 - bombola da 10 L — Air Liquide Italia Gas e Servizi S.r.l. · Class IIa
- Pulmoguard — SDI DIAGNOSTICS, INC. · Class II
- Neonatal Flow Sensor — Respironics Novametrix, LLC · Class IIa
- Pulmoguard — SDI DIAGNOSTICS, INC. · Class II
- 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Polytechnic Resources, Inc.
Sources (1)
- FDA UDI 218df938-f770-4e66-8bdd-1ecaa24ed998 33 fields · synced May 31, 2026