18 in (46 cm) Q2 Extension set w/ standard bore tubing

Basic Information

• Brand Name: 18 in (46 cm) Q2 Extension set w/ standard bore tubing
• Primary DI: 00634624095465
• Version / Model: 9546
• Catalog Number: 9546
• Company Name: QUEST MEDICAL INC
• Labeler DUNS: 041810693
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-29
• Public Version: 4
• Public Version Date: 2019-06-11
• Public Version Status: Update
• Public Device Record Key: 0d95a32d-4248-4fba-aae8-a7fd702d9770
• Distribution End Date: 2019-02-13

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
FPK	Tubing, Fluid Delivery	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20634624095469	GS1	Shipper	50	Not in Commercial Distribution	2019-02-13
Primary	00634624095465	GS1

Premarket Submissions

Submission Number	Supplement Number
K800825	000