Trulink 306655-003

GUDID 10841522103339

PKGD CABLE,CARDIAC OUTPU T,EDWARDS,ROHS

Statcorp Medical

Electrocardiographic lead set, reusable

• Primary Device ID: 10841522103339
• NIH Device Record Key: 3785ef0b-6f9f-4492-8698-8becb4665ddb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trulink
• Version Model Number: Patient cables & ECG leadwires
• Catalog Number: 306655-003
• Company DUNS: 602075905
• Company Name: Statcorp Medical
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522103339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103142

FDA Product Code

• DSI: DETECTOR AND ALARM, ARRHYTHMIA

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2023-10-23
• Device Publish Date: 2017-05-03

On-Brand Devices [Trulink]

• 10841522103339: PKGD CABLE,CARDIAC OUTPU T,EDWARDS,ROHS
• 10841522130441: BP CUFF,SL,SOFT,1T,CHILD,12-16,HP,EA
• 10841522130434: BP CUFF,SL,NYLON,1T,CHILD,12-16,HP,EA