Identity
- Trade Name
- UltraCW®II FDA UDI
- Generic Name
- Cell washer IVD FDA UDI
- Device Name
- Automated Cell Washing System FDA UDI
- Model / Reference
- UltraCW II FDA UDI
- Description
- Automated Cell Washing System FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 00816394020933 FDA UDI
- FDA Product Code
- KSN FDA UDI
- GMDN Term
- Cell washer IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9285 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
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
Yes
FDA UDI
Category: Cell washer IVD
UltraCW®II by HELMER Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cell washer IVD.
- COBE® 2991 — Terumo BCT, Inc.. · Class II
- UltraCW® — HELMER 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
- HELMER Inc.
Sources (1)
- FDA UDI 69efa694-e2f2-4305-b541-c6d1f248c9a0 35 fields · synced May 30, 2026