HEATING OVEN H-PLUS

Basic Information

• Brand Name: HEATING OVEN H-PLUS
• Primary DI: 08435389830269
• Version / Model: BTI H-PLUS
• Company Name: BIOTECHNOLOGY INSTITUTE SL
• Labeler DUNS: 461665312
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-30
• Public Version: 1
• Public Version Date: 2026-02-09
• Public Version Status: New
• Public Device Record Key: 50fae427-92e4-4469-9b9a-7a734d114e65

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
21087	Forced-air laboratory oven	A mains electricity (AC-powered) device with a heating chamber designed to provide fan-assisted convection to ensure a homogenous temperature profile in the chamber. It is used for laboratory procedures that involve drying, heating, and sterilizing objects. It typically operates at temperatures from 10? Celsius above ambient temperature to 250/300? Celsius. It is available in a variety of designs and chamber sizes, and the chamber is typically lined with corrosion-proof materials (e.g., stainless steel). The device is thermally insulated, has manual or microprocessor-operated controls, heating elements, and time and temperature sensors.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08435389830269	GS1