ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets

Basic Information

• Brand Name: ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets
• Primary DI: 00810008212561
• Version / Model: 5060 ONE-CARE PRESS & LOCK SBCWS 25G x 0.75’’, Luer Adapter, 12'' Tube
• Catalog Number: 5060
• Company Name: MediVena, LLC
• Labeler DUNS: 080740980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-27
• Public Version: 1
• Public Version Date: 2024-10-07
• Public Version Status: New
• Public Device Record Key: 32794545-70c3-4b3e-8e6f-5546e2154a09

Device Description

ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets 25G x 0.75'’, Orange, Luer Adapter, 12'' Tube, 50/bx, 4bx/cs or 20bx/cs

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: 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
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60579	Luer-ended blood collection tube spike	A device intended to be used during patient blood collection to facilitate transfer of a clinical blood specimen from blood collection tubing or a needle to a blood specimen receptacle (e.g., evacuated blood collection tube, adapted syringe). It is designed to be fitted to a blood collection tube holder, where it connects to the tubing or needle via a Luer connection at one end, and penetrates an evacuated blood collection tube at the other end for blood collection. This is a single-use device.	No	Active
65416	Basic intravenous administration set, invasive	A collection of devices which includes a hypodermic needle (e.g., venous butterfly/scalp vein needle) intended to conduct fluids from an intravenous (IV) fluid container to a patient's venous system during administration; it may also be used for blood collection. In addition to the needle, the set may include tubing, connectors, chambers, clamps, gauze pads, alcohol pads and dressings; a bag/bottle may also be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00810008212578	GS1	Box	50	In Commercial Distribution
Primary	00810008212561	GS1
Package	00810008212585	GS1	Case	4	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K151991	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	25	Gauge
Length	0.75	Inch