Butterfly Needle Phlebotomy Kit

Basic Information

• Brand Name: Butterfly Needle Phlebotomy Kit
• Primary DI: 00860009842281
• Version / Model: K-INV-PHLEBOTOMY-BN/000
• Company Name: Labcorp Genetics Inc
• Labeler DUNS: 119359774
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-13
• Public Version: 2
• Public Version Date: 2025-06-26
• Public Version Status: Update
• Public Device Record Key: 1acdebae-298c-4e8a-bbfb-23f001b49ad0

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OFM	Phlebotomy Blood Collection Kit	Cardiovascular	870.2750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58497	Blood collection set, invasive	A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009842281	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]