ACE

Basic Information

• Brand Name: ACE
• Primary DI: 00614950017072
• Version / Model: 0039940
• Catalog Number: 0039940
• Company Name: ACE SURGICAL SUPPLY CO., INC.
• Labeler DUNS: 042763706
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-10-10
• Public Version: 1
• Public Version Date: 2019-10-18
• Public Version Status: New
• Public Device Record Key: b05f19d3-8bd5-48bf-9343-5eeb8d2435c3

Device Description

CATHETER ONLY 14G 2" NS TEFLON PLAS HUB 10/PKG L/F

Device Characteristics

• Single Use: No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCB	NEEDLE, CATHETER	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
18067	Intravenous line recessed-needle connector	A sterile device designed to allow access to either the Y-site of an intravenous (IV) line or an injection adaptor on the infusion catheter. Typically, a needle located inside a plastic housing can be inserted into a standard septum and a Luer fitting located at the opposite end allows the connection of a syringe or infusion set. A manual or automated mechanism moves the housing to protect the operator from the needle once the infusion is finished. The device is intended to eliminate an exposed needle after administration of medications. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00614950017072	GS1
Unit of Use	10614950017079	GS1

Customer Contacts

• Phone: [phone] ext. 214
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	2	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: No special storage conditions required