Kew Medical

Basic Information

• Brand Name: Kew Medical
• Primary DI: 10816415020116
• Version / Model: QEG6211
• Company Name: DOUGLAS MEDICAL PRODUCTS, INC.
• Labeler DUNS: 121040922
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2017-09-15
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: a356aa9b-8390-45c2-8a75-9d82d6b0a793

Device Description

5" Bi-Fuse IV Minibore Extension Set, Needleless Connectors(2)(Bonded), Male Luer Lock (0.13 m) Length- Box

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: Yes
• 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
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
Primary	10816415020116	GS1
Unit of Use	00816415020119	GS1