Geratherm Thermometer Sheaths

Basic Information

• Brand Name: Geratherm Thermometer Sheaths
• Primary DI: 00614801100304
• Version / Model: Sheaths fits non mercury glass thermometers
• Catalog Number: 10030
• Company Name: R.G. ENTERPRISES (U.S.A.), INC.
• Labeler DUNS: 928998905
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 5d9028e9-9b81-43c4-a25c-b74db6337962

Device Description

Probe Covers (TIDI) are a latex free barrier used for Geratherm mercury free oral or rectal thermometers. They are a single use disposable item.

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• 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
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42391	Capillary thermometer cover	A device intended to be used as a physical barrier for an alcohol or mercury capillary thermometer to prevent cross-contamination between patients and/or environmental exposure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00614801100304	GS1
Package	10614801100301	GS1	Box	100	In Commercial Distribution

Customer Contacts

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