Identity
- Trade Name
- APOTECA FDA UDI
- Generic Name
- Hazardous fluid syringe FDA UDI
- Device Name
- Pharmacy compounding dosing device FDA UDI
- Model / Reference
- ASN-50-B-NCE FDA UDI
- Description
- Pharmacy compounding dosing device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060304050984 FDA UDI
- 510(k) Number
- K132011 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Hazardous fluid syringe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hazardous fluid syringe
Apoteca by Aea Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hazardous fluid syringe.
Cleared under the same submission
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
- Aea Srl
Sources (1)
- FDA UDI ef2de2d3-ecd8-4d40-9dd5-717ade981322 34 fields · synced Jun 1, 2026