Identity
- Trade Name
- Curaplex FDA UDI
- Generic Name
- Pulmonary function testing filter/mouthpiece FDA UDI
- Device Name
- MOUTHPIECE,RUBBER,DISP,INDIV WRAPPED 100/BX FDA UDI
- Model / Reference
- 301-PFR64IWMP FDA UDI
- Description
- MOUTHPIECE,RUBBER,DISP,INDIV WRAPPED 100/BX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812574023862 FDA UDI
- FDA Product Code
- BYP FDA UDI
- GMDN Term
- Pulmonary function testing filter/mouthpiece FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5620 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulmonary function testing filter/mouthpiece
Curaplex by Tri-Anim Health Services, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Tri-Anim Health Services, Inc.
Sources (1)
- FDA UDI 2515517b-ec18-4c64-bbba-1a2749a8d7f4 33 fields · synced Jun 8, 2026