CLR Port Injector

Basic Information

• Brand Name: CLR Port Injector
• Primary DI: 00850052377007
• Version / Model: S012-01-016
• Company Name: CLR Medical
• Labeler DUNS: 080279373
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-29
• Public Version: 2
• Public Version Date: 2024-12-09
• Public Version Status: Update
• Public Device Record Key: 6c1bfd62-89f9-4654-8c88-7902814ffc02

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCE	Adaptor, Catheter	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64512	Closed-wound drain connection tubing set	A device collection which includes flexible, noninvasive tubing (typically single or Y-shaped) and associated items (typically connectors, clamps, one-way valve and/or filter) intended to provide a connection between a surgical drain(s)/catheter(s) and a wound drainage container and/or suction source (the catheter, container and suction source are not included) to drain a closed wound. It is not intended to connect components of a surgical suction system (i.e., not used during general surgery). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850052377021	GS1		20	In Commercial Distribution
Primary	00850052377007	GS1