Straight Needle Phlebotomy Kit

Basic Information

• Brand Name: Straight Needle Phlebotomy Kit
• Primary DI: 00860009842274
• Version / Model: K-INV-PHLEBOTOMY-SN/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: 52c3c8ee-0317-4a32-82ac-fc2bdd65dab6

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
35209	Non-fixed blood collection needle	A sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient; it does not include wings for fixation/placement (i.e., not a venous butterfly/scalp vein needle). It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike and/or a safety cover; however, it does not include blood collection tubing or a tube holder (i.e., not a set). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009842274	GS1

Customer Contacts

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