Identity
- Trade Name
- Para-Pak ULTRA SAF Fixative / Clean Vial FDA UDI
- Generic Name
- Faecal specimen container IVD, fixative FDA UDI
- Device Name
- The Para-Pak Systems are convenient systems for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. It is designed for easy use by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation. FDA UDI
- Model / Reference
- 380212 FDA UDI
- Description
- The Para-Pak Systems are convenient systems for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. It is designed for easy use by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation. FDA UDI
Identifiers
- Catalog Number
- 380212 FDA UDI
- Primary DI / UDI-DI
- 00840733103131 FDA UDI
- FDA Product Code
- FMH FDA UDIIGG FDA UDI
- GMDN Term
- Faecal specimen container IVD, fixative FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 FDA UDI864.4010 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Para-Pak ULTRA SAF Fixative / Clean Vial by Meridian Bioscience, Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Meridian Bioscience, Inc.
Sources (2)
- FDA UDI c2cce6a5-59fe-4fee-a2bb-0418f5f8b02b 37 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 2, 2026