Identity
- Trade Name
- Helmer FDA UDI
- Generic Name
- Platelet incubator FDA UDI
- Device Name
- Environmental chamber for storage of platelet concentrate FDA UDI
- Model / Reference
- PC3200-PRO FDA UDI
- Description
- Environmental chamber for storage of platelet concentrate FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816394021671 FDA UDI
- FDA Product Code
- KSH FDA UDI
- GMDN Term
- Platelet incubator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9575 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
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 incubator
Helmer by HELMER Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Platelet incubator.
- Boekel Large Platelet Incubator — BOEKEL INDUSTRIES, INC. · Class II
- Boekel Small Platelet Incubator — BOEKEL INDUSTRIES, INC. · Class II
- Boekel Floor Standing Platelet Incubator Agitator — BOEKEL INDUSTRIES, INC. · Class II
- Helmer — HELMER Inc. · Class II
- i.Series® — HELMER Inc. · Class II
- Helmer — HELMER Inc. · Class II
- Helmer — HELMER Inc. · Class II
- i.Series® — 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 1107741b-66b6-4b63-b37f-6e015e353499 33 fields · synced May 30, 2026