CORD STICK 2003-001

GUDID 0861916000307

The Cord Stick Multiple Draw System is indicated for collection of blood from the umbilical cord after delivery of a new born infant. The blood is for

CORD STICK CORPORATION

Blood collection set, invasive

• Primary Device ID: 0861916000307
• NIH Device Record Key: 85f1f7e9-178b-4c0a-8b19-5bf82730a1ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORD STICK
• Version Model Number: MULTIPLE DRAW SYSTEM
• Catalog Number: 2003-001
• Company DUNS: 053371576
• Company Name: CORD STICK CORPORATION
• Device Count: 24
• 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 1-800-830-9118
• Email: REGARDEZ@CORDSTICK.COM
• Phone: 1-800-830-9118
• Email: REGARDEZ@CORDSTICK.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861916000307 [Unit of Use]
GS1	0861916000307 [Package]; Contains: 30861916000307; Package: BOX [24 Units]; In Commercial Distribution
GS1	30861916000307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031058

FDA Product Code

• KNA: Instrument, Manual, Specialized Obstetric-Gynecologic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

On-Brand Devices [CORD STICK ]

• 00861916000306: The Cord Stick Multiple Draw System is indicated for collection of blood from the umbilical cord
• 0861916000304: The Cord Stick Multiple Draw System is indicated for collection of blood from the umbilical cord
• 0861916000307: The Cord Stick Multiple Draw System is indicated for collection of blood from the umbilical cord