EQUALINE

Basic Information

• Brand Name: EQUALINE
• Primary DI: 00041163232143
• Version / Model: 753
• Company Name: SUPERVALU INC.
• Labeler DUNS: 006961411
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: db433ccb-9351-4982-9fa2-4a1cd17e8239

Device Description

25 pack of probe covers. A device intended to be used as a physical barrier between the patient and the probe of a thermometer to prevent cross-contamination between patients. This is a single-use device.

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: 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
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	40041163232141	GS1	case	24	In Commercial Distribution
Package	20041163232147	GS1	inner carton	6	In Commercial Distribution
Primary	00041163232143	GS1

Customer Contacts

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