VSE3010XD - Empty Bag 300 mL 6-Way Man

Basic Information

• Brand Name: VSE3010XD - Empty Bag 300 mL 6-Way Man
• Primary DI: 03567050052740
• Version / Model: VSE
• Catalog Number: VSE3010XD
• 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: 1d075fe7-fa2f-428b-956e-fed1f9e68b1c

Device Description

300 mL Empty Bag for Pooling of Blood Components.

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
44033	Blood donor set, single-pack	An assembly of sterile devices intended to be used to collect whole blood from a donor. It includes a container (a single flexible bag) with anticoagulation solution, 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 blood is tested, stored, and infused from the container 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	13567050052747	GS1	Carton	20	In Commercial Distribution
Primary	03567050052740	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BK030008	0