Identity
- Trade Name
- Curaplex FDA UDI
- Generic Name
- Pulmonary function testing filter/mouthpiece FDA UDI
- Device Name
- FILTER,ELLIPTICAL,27.0ID,30.1OD FDA UDI
- Model / Reference
- 301-PFR9WE2 FDA UDI
- Description
- FILTER,ELLIPTICAL,27.0ID,30.1OD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812574026405 FDA UDI
- 510(k) Number
- K042758 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 25.4 Millimeter FDA UDI
Category: Pulmonary function testing filter/mouthpiece
Curaplex by Tri-Anim Health Services, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K042758 also covers:
- MCG Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
- MGC Diagnostics — MEDICAL GRAPHICS CORP.
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
- Tri-Anim Health Services, Inc.
Sources (1)
- FDA UDI 5a0b4786-25e4-4636-b974-3f226d25702a 35 fields · synced May 30, 2026