N/A

Basic Information

• Brand Name: N/A
• Primary DI: 16974594960228
• Version / Model: 15ml
• Company Name: HBH BIOTECHNOLOGY LIMITED
• Labeler DUNS: 404071076
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-01
• Public Version: 1
• Public Version Date: 2025-03-10
• Public Version Status: New
• Public Device Record Key: 88d2dc49-bc9e-419d-a9b6-ca377c825970

Device Description

Test tube with test tube plug for reagent storage

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	864.9125	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46721	Disposable vacuum tubing	A sterile length of flexible tube intended to be used as a connection line between a vacuum source and a medical device, medical equipment, or a medical system that is dependent upon suction to operate or function. It is typically made of malleable synthetic polymer material(s) (e.g., plastic, silicone) and is designed with a thick wall to prevent collapse due to the negative pressure of the vacuum; it is available in a variety of lengths, including standard coil lengths. This device is used when sterile conditions are required (e.g., for an autologous blood transfusion system). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26974594960225	GS1		169	In Commercial Distribution
Primary	16974594960228	GS1