VQE2001XD - 4 Empty Bags 300 mL

Basic Information

• Brand Name: VQE2001XD - 4 Empty Bags 300 mL
• Primary DI: 03567050069908
• Version / Model: VQE
• Catalog Number: VQE2001XD
• Company Name: MACO PRODUCTIONS
• Labeler DUNS: 265492868
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 1962544c-6fad-4256-b778-b25855360a05

Device Description

300ml Quad Splitting Empty Bags.

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: 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: 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
CAK	Microfilter, Blood Transfusion	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46347	Blood donor set, quad-pack	An assembly of sterile devices intended to be used to collect whole blood from a donor and separate the red blood cells, plasma, and platelets. It includes four containers (flexible bags) ? one or more with anticoagulation solution and/or preservatives for red blood cells, tubing, and an attached needle for venipuncture. It may include integrated features such as an in-line leukocyte filter, pre-donation blood sampling device, and/or needle stick prevention device. After collection, the red blood cells, plasma, and platelets are separated, via centrifugation, into separate containers and subsequently tested, stored, and infused from the containers when needed. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	13567050069905	GS1	Carton	15	In Commercial Distribution
Primary	03567050069908	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BK030008	0