SECURE®

Basic Information

• Brand Name: SECURE®
• Primary DI: 20812496011477
• Version / Model: 66616
• Catalog Number: 66616
• Company Name: METRIX COMPANY, THE
• Labeler DUNS: 043046283
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2023-06-22
• Public Version Status: Update
• Public Device Record Key: 71a91cad-bb6e-4a2a-a7e1-808b20322c19

Device Description

EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET (8 SETS OF 5 BAGS)

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
KPE	Container, I.V.	General Hospital	880.5025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35127	Intravenous administration bag/bottle	An empty pouch or bottle made of plastic or glass intended to contain a fluid (e.g., saline, medication) for intravenous (IV) administration; some types may in addition be intended for enteral feeding applications. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an IV administration set] and is not intended to be directly connected to the IV catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50812496011478	GS1	Cardboard Carton	8	In Commercial Distribution
Primary	20812496011477	GS1
Unit of Use	00812496011473	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K960581	000

Device Sizes

Type	Value	Unit	Text
Total Volume	1500	Milliliter