Tech-Med

Basic Information

• Brand Name: Tech-Med
• Primary DI: 00665973017099
• Version / Model: 3211
• Catalog Number: 3211
• Company Name: Dukal LLC
• Labeler DUNS: 791014871
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2022-05-23
• Public Version Status: Update
• Public Device Record Key: 15b763ea-7622-46d9-8f68-1802db2c1e89
• Distribution End Date: 2020-10-14

Device Description

Thermometer Probe Covers

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
FLL	Thermometer, electronic, clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13116	Electronic thermometer probe cover	A device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20665973017093	GS1	Case	12	Not in Commercial Distribution	2020-10-14
Package	10665973017096	GS1	Box	12	Not in Commercial Distribution	2020-10-14
Primary	00665973017099	GS1
Unit of Use	30665973017090	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K903590	000