Ecomed Angiographic

Basic Information

• Brand Name: Ecomed Angiographic
• Primary DI: 00855009006115
• Version / Model: 128-200301A
• Catalog Number: 128-200301A
• Company Name: ECOMED SOLUTIONS, LLC
• Labeler DUNS: 079814353
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-21
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 63c89f09-0739-4488-8a5a-ef1c58672e44

Device Description

MR 60ml LF Syringe Kit Includes (1) 90" Y-coiled tubing (1) large spike

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• 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
DXT	Injector And Syringe, Angiographic	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16545	Angiography kit	A collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not 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	10855009006112	GS1	Case	50	In Commercial Distribution
Primary	00855009006115	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	60	Milliliter
Length	90	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry