Rospital Productos Medicos

Basic Information

• Brand Name: Rospital Productos Medicos
• Primary DI: 00812460027172
• Version / Model: SYFTY5215
• Catalog Number: SYFTY5215
• Company Name: ATLAS MEDICAL PRODUCTS LLC
• Labeler DUNS: 013112308
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-06
• Public Version: 1
• Public Version Date: 2020-07-14
• Public Version Status: New
• Public Device Record Key: f3ae06a3-12c8-4068-9f3e-b129198eeaec

Device Description

HYPODERMIC SAFETY NEEDLE WITH 5CC SYRINGE LUER LOCK 21 X 1 1/2",EA.

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
FMF	Syringe, Piston	General Hospital	880.5860	2
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47017	General-purpose syringe, single-use	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.	No	Active
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
Package	10812460027179	GS1	INNER BOX	100	In Commercial Distribution
Primary	00812460027172	GS1
Package	20812460027176	GS1	CASE	18	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K190183	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			HYPODERMIC SAFETY NEEDLE WITH 5CC SYRINGE LUER LOCK 21 X 1 1/2",EA.