Guerbet Ext/Inj line Straight CT/MR

Basic Information

• Brand Name: Guerbet Ext/Inj line Straight CT/MR
• Primary DI: 13661657031058
• Version / Model: PN-MDX3515M
• Catalog Number: 240004
• Company Name: CAIR LGL
• Labeler DUNS: 380834713
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-24
• Public Version: 1
• Public Version Date: 2023-05-02
• Public Version Status: New
• Public Device Record Key: ab063b61-f9a9-403a-afbf-eda14dfd82fd

Device Description

150 cm Straight Extension/Injection Line for CT & MRI

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: 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
FPA	Set, Administration, Intravascular	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	13661657031058	GS1
Package	23661657031055	GS1	Carton box	25	In Commercial Distribution
Package	53661657031056	GS1	Carton box	100	In Commercial Distribution
Package	33661657031052	GS1	Carton box	400	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K171118	000