Medline

Basic Information

• Brand Name: Medline
• Primary DI: 10888277697669
• Version / Model: MDSLWR102
• Catalog Number: MDSLWR102
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-15
• Public Version: 1
• Public Version Date: 2022-07-25
• Public Version Status: New
• Public Device Record Key: a7f7714f-b90e-49eb-a01b-8574efbe9740

Device Description

LEADWIRE,CABLE,REUS,3-LEAD,GE

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: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• 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
DSA	CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)	Cardiovascular	870.2900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61821	Electrocardiographic lead set, single-use	A collection of non-sterile, noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array to assist electrode placement. It is not designed with radiolucent properties. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888277697669	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: High: 80 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 41 – 104 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: High: 93 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 131 Degrees Fahrenheit
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal