MPS 3 ND Delivery Set w/AA w/183 Line (16C)

Basic Information

• Brand Name: MPS 3 ND Delivery Set w/AA w/183 Line (16C)
• Primary DI: 00634624530379
• Version / Model: 5ND3102-AS
• Company Name: QUEST MEDICAL INC
• Labeler DUNS: 041810693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-05
• Public Version: 2
• Public Version Date: 2021-10-19
• Public Version Status: Update
• Public Device Record Key: 9ebdb9f5-d386-44b4-8a22-64799e544a24

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: 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
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	870.4240	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16163	Cardioplegia solution administration kit	A collection of devices intended to be used to infuse cardioplegia solution into the heart to interrupt its contractions during cardiopulmonary bypass surgery. It typically consists of tubing/adaptor, a filter, and a heat exchanger. This is single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20634624530373	GS1		10	In Commercial Distribution
Primary	00634624530379	GS1

Premarket Submissions

Submission Number	Supplement Number
K201984	000