Identity
- Trade Name
- XCELL FDA UDI
- Generic Name
- Blood storage solution, anticoagulation FDA UDI
- Device Name
- ACD-A 13mL Vial Anticoagulant (PN 70-111) FDA UDI
- Model / Reference
- ACD-A-13 FDA UDI
- Description
- ACD-A 13mL Vial Anticoagulant (PN 70-111) FDA UDI
Identifiers
- Primary DI / UDI-DI
- B708ACDA130 FDA UDI
- FDA Product Code
- ORG FDA UDI
- GMDN Term
- Blood storage solution, anticoagulation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9245 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: Blood storage solution, anticoagulation
Xcell by Apex Biologix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood storage solution, anticoagulation.
- Camco — CAMBRIDGE DIAGNOSTIC PRODUCTS, INC. · Class I
- XCELL — APEX BIOLOGIX · 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
- Apex Biologix
Sources (1)
- FDA UDI d7199993-50ad-4d66-bf04-52e7a8c7fefd 35 fields · synced Jun 8, 2026