Lynn Medical - Ambulatory Kit

Basic Information

• Brand Name: Lynn Medical - Ambulatory Kit
• Primary DI: 00851491007210
• Version / Model: 311133
• Catalog Number: 311133
• Company Name: Lynn Medical Instrument Co.
• Labeler DUNS: 058810771
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-08
• Public Version: 1
• Public Version Date: 2018-11-08
• Public Version Status: New
• Public Device Record Key: 64ab4d1f-78de-4c42-9b82-7e8143e30a39

Device Description

Ambulatory Monitoring Kit - AccuSensor LM33-1-30

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
62149	Electrocardiographic long-term ambulatory recording support kit	A collection of non-sterile, noninvasive devices intended to be used in conjunction with an electrocardiographic (ECG) long-term ambulatory recorder (holter monitor) to facilitate recording. It includes an ECG electrode(s), batteries (to power the recorder), devices intended to assist electrode application (e.g., razor, electrode placement guide, conductive gel, skin cleaning wipe, tape), and may include other patient-supportive devices (e.g., diary/notebook); the recorder is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10851491007217	GS1	CS	20	In Commercial Distribution
Primary	00851491007210	GS1
Package	20851491007214	GS1	CS	50	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 32 Degrees Celsius