2100-SX2 FINAL FEATURE ITEM

GUDID 00816787024173

PARKS MEDICAL ELECTRONICS, INC.

Cardiac arrhythmia monitoring system

• Primary Device ID: 00816787024173
• NIH Device Record Key: 9f8e71e9-0b11-4374-82bb-576b4adb3fb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2100-SX2 FINAL FEATURE ITEM
• Version Model Number: 2100-SX2 FFI
• Company DUNS: 009041773
• Company Name: PARKS MEDICAL ELECTRONICS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)547-6427
• Email: twelker@parksmed.com
• Phone: +1(800)547-6427
• Email: twelker@parksmed.com
• Phone: +1(800)547-6427
• Email: twelker@parksmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816787024173 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944495

FDA Product Code

• MHX: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by PARKS MEDICAL ELECTRONICS, INC.

• 00816787024319 - 3.9MHz Pencil Probe 7 Foot ODU connector: 2022-05-23
• 00816787024326 - 8.1MHz Pencil Probe 7 Foot ODU connector: 2022-05-23
• 00816787024333 - 8.3MHz Pencil Probe 7 Foot ODU connector: 2022-05-23
• 00816787024340 - 8.7MHz Pencil Probe 7 Foot ODU connector: 2022-05-23
• 00816787024357 - 9.1MHz Pencil Probe 7 Foot ODU connector: 2022-05-23
• 00816787024364 - 9.4MHz Pencil Probe 7 Foot ODU connector: 2022-05-23
• 00816787024371 - 9.7MHz Pencil Probe 7 Foot ODU connector: 2022-05-23
• 00816787024302 - 8.1 MHz Pencil Probe 7FT Contoured: 2021-05-24