Rospital Productos Medicos

Basic Information

• Brand Name: Rospital Productos Medicos
• Primary DI: 00812460027660
• Version / Model: AMPFT08
• Catalog Number: AMPFT08
• 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: 85b38b1e-3067-43f0-a362-2e6995a109ae

Device Description

FEEDING TUBES 8FR, X-RAY, 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: Yes
• 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
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58974	Enteral feeding/decompression tube clearing stem	A non-sterile, sheath-covered device intended to be used to mechanically clear a clog in an in situ nasogastric, nasoenteral, gastrostomy and/or jejunostomy tube, used for feeding and/or decompression, to maintain luminal patency. It consists of a sheath and a stem clog disrupter (e.g., a wire or rod) designed to be magnetically coupled with a motorized actuator which facilitates the forward and backward movement of the disrupter inside the sheath. It typically has a collar to restrict the inserted length, and a diameter, appropriate for the installed feeding/decompression tube. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10812460027667	GS1	INNER	100	Not in Commercial Distribution	2020-07-06
Primary	00812460027660	GS1
Package	20812460027664	GS1	CASE	5	Not in Commercial Distribution	2020-07-06

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			FEEDING TUBES 8FR, X-RAY, EA.