Kurin Blood Collection Set, 21 Ga, BD Vacutainer

Basic Information

• Brand Name: Kurin Blood Collection Set, 21 Ga, BD Vacutainer
• Primary DI: 00851682007036
• Version / Model: D-11221
• Company Name: PATHWAY, LLC
• Labeler DUNS: 080312381
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-13
• Public Version: 5
• Public Version Date: 2020-07-23
• Public Version Status: Update
• Public Device Record Key: e3418003-cfd9-4c44-96a3-777612826121
• Distribution End Date: 2018-07-23

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
58490	Venous butterfly needle/set	An invasive, hollow, tubular, metal device intended to puncture a vein to collect blood and/or for transient (<24 hours) or short-term (<= 30 days) administration of intravenous (IV) fluids. It includes wings for fixation/placement and may include tubing and/or connectors; however, it does not include accessories to facilitate introduction (e.g., stylet). The device may also be referred to as butterfly needle or scalp vein needle. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20851682007030	GS1		4	Not in Commercial Distribution	2018-07-23
Package	10851682007033	GS1		50	Not in Commercial Distribution	2018-07-23
Primary	00851682007036	GS1