Trulink 715-3012-00

GUDID 10841522130441

BP CUFF,SL,SOFT,1T,CHILD,12-16,HP,EA

STATCORP MEDICAL

Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use Blood pressure cuff, single-use

• Primary Device ID: 10841522130441
• NIH Device Record Key: 02d67139-bcd1-4057-84c1-e40b6b50e37b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trulink
• Version Model Number: SoftCheck BP Cuffs
• Catalog Number: 715-3012-00
• Company DUNS: 038942055
• 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522130441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940214

FDA Product Code

• DXQ: blood pressure cuff

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: 2024-06-17
• Device Publish Date: 2024-06-07

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