PRN

Basic Information

• Brand Name: PRN
• Primary DI: 30382903851141
• Version / Model: 385114
• Catalog Number: 385114
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 124987988
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2023-08-10
• Public Version: 1
• Public Version Date: 2023-08-18
• Public Version Status: New
• Public Device Record Key: 3027b071-8f6a-4e63-b707-7d61e199d69f

Device Description

PRN Adapter 0.3ml

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
FPA	Set, administration, intravascular	General Hospital	880.5440	2
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16858	Catheter injection port	A device intended to be placed on the Luer end of a catheter or intravenous (IV) tubing as a site of injection of substances into the in situ catheter/tubing. It is also intended to be used as a heparin lock by keeping the heparin flush solution in the catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50382903851145	GS1	Case	4	In Commercial Distribution
Primary	30382903851141	GS1
Unit of Use	00382903851140	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K933467	000

Device Sizes

Type	Value	Unit	Text
Total Volume	0.3	Milliliter