Identity
- Trade Name
- i.Series® FDA UDI
- Generic Name
- Ultralow-temperature laboratory freezer FDA UDI
- Device Name
- Ultra-Low Freezer, 16 cu ft FDA UDI
- Model / Reference
- iUF116 FDA UDI
- Description
- Ultra-Low Freezer, 16 cu ft FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816394020865 FDA UDI
- FDA Product Code
- KSE FDA UDI
- GMDN Term
- Ultralow-temperature laboratory freezer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9700 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: Ultralow-temperature laboratory freezer
i.Series® by HELMER Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultralow-temperature laboratory freezer.
- Thermo Scientific Forma Freezer — KEY SCIENTIFIC INC · Class II
- Haier — Qingdao Haier Biomedical Co Ltd · Class II
- Fisherbrand™ Isotemp™ Ultra-Low-Temperature Freezer — KEY SCIENTIFIC INC · Class II
- Thermo Scientific HERAfreeze — KEY SCIENTIFIC INC · Class II
- Fisherbrand™ Isotemp™ Ultra-Low-Temperature Freezer — KEY SCIENTIFIC INC · Class II
- Fisherbrand™ Isotemp™ Ultra-Low-Temperature Freezer — KEY SCIENTIFIC INC · Class II
- Thermo Scientific — KEY SCIENTIFIC INC · Class II
- VWR — Thermo Fisher Scientific (Asheville) LLC · 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 0e73dd90-f73d-4d8e-97ed-e0ef136caafe 34 fields · synced May 30, 2026