KBMED

Basic Information

• Brand Name: KBMED
• Primary DI: 00850016172372
• Version / Model: SBCN23-1H
• Company Name: KB Medical (group), Inc.
• Labeler DUNS: 105002071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-21
• Public Version: 1
• Public Version Date: 2025-05-29
• Public Version Status: New
• Public Device Record Key: 72637fe6-6355-4189-84ed-c46d4144acb7

Device Description

Safety blood collection set with pre-attached holder, 23G*3/4" with 12" tubing

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	862.1675	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	00850016172372	GS1

Premarket Submissions

Submission Number	Supplement Number
K232881	000