BD Insyte Autoguard Shielded IV Catheter

Basic Information

• Brand Name: BD Insyte Autoguard Shielded IV Catheter
• Primary DI: 00382903818341
• Version / Model: 381834
• Catalog Number: 381834
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 124987988
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-22
• Public Version: 2
• Public Version Date: 2024-02-26
• Public Version Status: Update
• Public Device Record Key: cac4399d-f1d3-41b8-9d0e-41229a1aebce

Device Description

INSYTE AUTOGUARD PNK 20GA X 1.16IN

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: MR Conditional
• 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
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64574	Peripheral intravenous cannula	A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30382903818342	GS1	Shelfpack	50	In Commercial Distribution
Primary	00382903818341	GS1
Package	50382903818346	GS1	Case	4	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K201075	000