Trulink 306655-003

GUDID 10841522103339

PKGD CABLE,CARDIAC OUTPU T,EDWARDS,ROHS

Statcorp Medical

Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable 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

Devices Manufactured by Statcorp Medical

• 10841522109355 - Ultracheck: 2023-10-25 ULTRACHECK LARGE ADULT SINGLE TUBE, MML
• 10841522109362 - Ultracheck: 2023-10-25 UC LARGE ADULT LONG SINGLE TUBE, MML
• 10841522109386 - Ultracheck: 2023-10-25 ULTRACHECK THIGH SINGLETUBE, MML
• 10841522109416 - Softcheck: 2023-10-25 BP CUFF,SC YLW VINYL,1T,SM.ADULT,18-26CM,HP,EA
• 10841522109423 - Softcheck: 2023-10-25 BP CUFF,SC YLW VINYL,1T,ADULT,26-35CM,HP,EA
• 10841522109461 - Softcheck: 2023-10-25 BP CUFF,SC YLW VINYL,1T,LG.ADULT,32-42CM,HP,EA
• 10841522110801 - Ultracheck: 2023-10-25 BP CUFF,UC NYLON,1T,LG.ADULT-L,35-44CM,FL,EA
• 10841522110863 - Ultracheck: 2023-10-25 BP CUFF,UC NYLON,1T,LG.ADULT-L,35-44CM,ML,EA