Identity
- Trade Name
- PFT Nose Clip with Foam Pads FDA UDI
- Generic Name
- Nose clip, single-use FDA UDI
- Device Name
- Disposable White Pulmonary Function Testing Nose Clip with Foam Pads FDA UDI
- Model / Reference
- PFT Nose Clip with Foam Pads FDA UDI
- Description
- Disposable White Pulmonary Function Testing Nose Clip with Foam Pads FDA UDI
Identifiers
- Catalog Number
- 166504 FDA UDI
- Primary DI / UDI-DI
- 00817081028201 FDA UDI
- FDA Product Code
- BXJ FDA UDI
- GMDN Term
- Nose clip, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6225 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nose clip, single-use
PFT Nose Clip with Foam Pads by A-M Systems, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- A-M Systems, Inc.
Sources (2)
- FDA UDI 6f4a5591-0e9f-4fd3-b786-7f78eae11bb8 35 fields · synced Jun 11, 2026
- EUDAMED 1 fields · synced Jun 11, 2026