LifeSync CB-AB 2001-0 (NS)

GUDID 00849593025430

Reusable, 12 Foot, Bipolar, Blue Cable, Angled, Non-Sterile

Advantage Medical Electronics, LLC

Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use

• Primary Device ID: 00849593025430
• NIH Device Record Key: a052ffba-e579-4ffd-8f1a-f0781e5f8374
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifeSync
• Version Model Number: AB 2001 (NS)
• Catalog Number: CB-AB 2001-0 (NS)
• Company DUNS: 080242300
• Company Name: Advantage Medical Electronics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849593025430 [Primary]
GS1	10849593025437 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953889

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-05
• Device Publish Date: 2023-09-27

On-Brand Devices [LifeSync]

• 00849593025461: Reusable, 10 Foot, Monopolar, Gray Cable, Straight Socket, Non-Sterile
• 00849593025454: Reusable, 10 Foot, Monopolar, Grey Cable, Bovie Plug to 90 Degree Female Socket, Non-Sterile
• 00849593025447: Reusable, 12 Foot, Bipolar, Blue Cable, Straight Forceps Socket, Non-Sterile
• 00849593025430: Reusable, 12 Foot, Bipolar, Blue Cable, Angled, Non-Sterile
• 00849593025478: LeadWear®, 12 Lead, Size 7L