Identity
- Trade Name
- Filter, Clear, Disposable,Viral/ Bacterial FDA UDI
- Generic Name
- Pulmonary function testing filter/mouthpiece FDA UDI
- Device Name
- Filter, Clear, Disposable,Viral/ Bacterial FDA UDI
- Model / Reference
- Filter, Clear, Disposable,Viral/ Bacterial - 155200 FDA UDI
- Description
- Filter, Clear, Disposable,Viral/ Bacterial FDA UDI
Identifiers
- Catalog Number
- 155200 FDA UDI
- Primary DI / UDI-DI
- 00817081024364 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulmonary function testing filter/mouthpiece
Filter, Clear, Disposable, Viral/ Bacterial by A-M Systems, 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
- 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
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
- A-M Systems, Inc.
Sources (1)
- FDA UDI 5fd41f01-c394-4e32-b867-2f8f5adadc34 34 fields · synced May 29, 2026