Identity
- Trade Name
- Helmer FDA UDI
- Generic Name
- Platelet agitator FDA UDI
- Device Name
- Platelet Agitator FDA UDI
- Model / Reference
- PF96-Pro FDA UDI
- Description
- Platelet Agitator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816394020995 FDA UDI
- FDA Product Code
- KSQ FDA UDI
- GMDN Term
- Platelet agitator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.9195 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: Platelet agitator
Helmer by HELMER Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Platelet agitator.
- Boekel Small Platelet Agitator — BOEKEL INDUSTRIES, INC. · Class I
- Boekel Large Platelet Agitator — BOEKEL INDUSTRIES, INC. · Class I
- Helmer — HELMER Inc. · Class I
- Horizon Series™ — HELMER Inc. · Class I
- i.Series® — HELMER Inc. · Class I
- Helmer — HELMER Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- HELMER Inc.
Sources (1)
- FDA UDI 312b4d35-07a3-44de-bce2-c7eb994839dc 34 fields · synced Jun 8, 2026