Identity
- Trade Name
- GRI-FILL FDA UDI
- Generic Name
- Pharmaceutical fluid-dispensing system FDA UDI
- Device Name
- GRI-FILL is a pharmacy compounding device (PCD) and as such is an electromechanical device controlled by software intended to deliver a specified concentration or proportion of ingredients different from the initial solutions. FDA UDI
- Model / Reference
- - FDA UDI
- Description
- GRI-FILL is a pharmacy compounding device (PCD) and as such is an electromechanical device controlled by software intended to deliver a specified concentration or proportion of ingredients different from the initial solutions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426314948258 FDA UDI
- FDA Product Code
- NEP FDA UDI
- GMDN Term
- Pharmaceutical fluid-dispensing system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Category: Pharmaceutical fluid-dispensing system
Gri-Fill by Laboratorios Grifols Sa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Mixing Tips — Gc America Inc. · Class II
- Mixing Tips — Gc America Inc. · Class II
- Mixing Tips — Gc America 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 |
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Manufacturer
- Manufacturer
- Laboratorios Grifols Sa
Sources (1)
- FDA UDI a35e3a69-4fd4-4a4c-a476-6b8fbc5d3f1e 33 fields · synced May 30, 2026