Dead End Stopper & Cap

Basic Information

• Brand Name: Dead End Stopper & Cap
• Primary DI: 00616784705729
• Version / Model: 7057
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2018-10-10
• Public Version: 1
• Public Version Date: 2018-11-12
• Public Version Status: New
• Public Device Record Key: 2e8c73b3-70a6-43f8-884b-a0ff71597165

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMG	Stopcock, I.V. Set	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32172	Intravenous line stopcock	A sterile valve that is typically a component of an intravenous (IV) administration set and designed to be manually-operated by healthcare staff to regulate the flow of intravenous solution delivered to a patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00616784705736	GS1		2000	In Commercial Distribution
Primary	00616784705729	GS1
Unit of Use	00616784705712	GS1

Premarket Submissions

Submission Number	Supplement Number
K172266	000