GCB Medical Supply

Basic Information

• Brand Name: GCB Medical Supply
• Primary DI: 00810184642909
• Version / Model: GCBIVT065C
• Catalog Number: GCBIVT065C
• Company Name: GCB MEDICAL LLC
• Labeler DUNS: 086699722
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-10
• Public Version: 1
• Public Version Date: 2025-07-18
• Public Version Status: New
• Public Device Record Key: c5f35094-6a32-4035-9800-94d0d95cdf3e

Device Description

GCB MEDICAL SAFETY PUSH BUTTON BLOOD COLLECTION SET 0.75IN NEEDLE, 23G, 12IN TUBE, W PREATTACHED HOLDER

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: No
• 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: Yes
• 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
FPA	Set, Administration, Intravascular	General Hospital	880.5440	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
Package	00810184642947	GS1	Inner box	40	In Commercial Distribution
Primary	00810184642909	GS1
Package	00810184642985	GS1	case	5	In Commercial Distribution

Customer Contacts

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