Isotemp™

FDA UDI

Class II (US FDA UDI)

by Thermo Fisher Scientific (Asheville) LLC

Identity

Trade Name: Isotemp™ FDA UDI
Generic Name: Ultralow-temperature laboratory freezer FDA UDI
Device Name: IUEC25286LA, Chest ULT 12.7 cu. ft., 115V, 60Hz FDA UDI
Model / Reference: IUEC25286LA FDA UDI
Description: IUEC25286LA, Chest ULT 12.7 cu. ft., 115V, 60Hz FDA UDI

Identifiers

Catalog Number: IUEC25286LA FDA UDI
Primary DI / UDI-DI: 00815773020557 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Ultralow-temperature laboratory freezer

Isotemp™ by Thermo Fisher Scientific (Asheville) LLC — 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
Helmer — 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: Thermo Fisher Scientific (Asheville) LLC

Sources (1)

FDA UDI 1c6ae776-7fc2-4afa-bc2b-9719767cf74c 34 fields · synced Jun 9, 2026