VACSURE SAFETY MULTI-SAMPLE NEEDLE

Basic Information

• Brand Name: VACSURE SAFETY MULTI-SAMPLE NEEDLE
• Primary DI: 00850014448004
• Version / Model: VM-1021
• Catalog Number: VM-1021
• Company Name: LABOTEK GROUP CORP
• Labeler DUNS: 117338398
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-23
• Public Version: 4
• Public Version Date: 2023-12-07
• Public Version Status: Update
• Public Device Record Key: 4c145367-78d4-48ec-8c07-a1cf1229e93f

Device Description

SAFETY MULTI-SAMPLE NEEDLE ONLY, 21G X 1 1/4", Each,

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: 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
59230	Hypodermic needle, single-use	A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly 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	00850014448004	GS1
Package	10850014448001	GS1	Inner Box	50	In Commercial Distribution
Package	20850014448008	GS1	Case	10	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			VACSURE SAFETY MULTI-SAMPLE NEEDLE ONLY, 21G X 1 1/4", Each,