DAR

Basic Information

• Brand Name: DAR
• Primary DI: 10884522019514
• Version / Model: 444SPA0000
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-04-15
• Public Version: 5
• Public Version Date: 2023-08-16
• Public Version Status: Update
• Public Device Record Key: 82c788e2-b581-4569-9e38-c421788a98da

Device Description

Saline Vial 0.9% Sodium Chloride Solution for Irrigation

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: No
• 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
BSY	CATHETERS, SUCTION, TRACHEOBRONCHIAL	Anesthesiology	868.6810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34923	Suction system catheter, general-purpose	A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884522019511	GS1	CASE	5	In Commercial Distribution
Primary	10884522019514	GS1
Unit of Use	10884521844858	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Total Inner Volume,15,Milliliter;