BD Insyte Autoguard

Basic Information

• Brand Name: BD Insyte Autoguard
• Primary DI: 00382903826346
• Version / Model: 382634
• Catalog Number: 382634
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 124987988
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 4
• Public Version Date: 2021-10-01
• Public Version Status: Update
• Public Device Record Key: bbbc0a64-fea1-400a-bc34-e5bf948856ba

Device Description

INSYTE AUTOG BC WING PNK 20GA X1.16IN

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: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: Yes
• 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	50382903826341	GS1	Case	4	In Commercial Distribution
Primary	00382903826346	GS1
Package	30382903826347	GS1	Shelfpack	50	In Commercial Distribution

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room Temperature