Rospital Productos Medicos

Basic Information

• Brand Name: Rospital Productos Medicos
• Primary DI: 00812460028612
• Version / Model: IVCT20
• Company Name: ATLAS MEDICAL PRODUCTS LLC
• Labeler DUNS: 013112308
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-02
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 46d4f7bf-34df-4c2a-b1e2-5e1e84ed1c2d

Device Description

I.V. CATHETER PEN TYPE 20 G X 1 1/4 100 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
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32151	Peripheral vascular intervention infusion catheter	A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10812460028619	GS1	INNER BOX	100	In Commercial Distribution
Primary	00812460028612	GS1
Package	20812460028616	GS1	CASE	20	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K142797	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			I.V. CATHETER PEN TYPE 20 G X 1 1/4 100 EA.