Introducer Kit for Impella®

Basic Information

• Brand Name: Introducer Kit for Impella®
• Primary DI: 00813502011609
• Version / Model: 0052-3006
• Catalog Number: 0052-3006
• Company Name: Oscor Inc.
• Labeler DUNS: 101835833
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-19
• Public Version: 4
• Public Version Date: 2019-06-07
• Public Version Status: Update
• Public Device Record Key: c0cc75fa-84e4-4da6-a4c0-d6e11df87140

Device Description

Hemostatic Peel Away Introducer System with Infusion Sideport, 23F

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYB	INTRODUCER, CATHETER	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58865	Vascular catheter introduction set, nonimplantable	A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813502011609	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K122084	000

Device Sizes

Type	Value	Unit	Text
Length	6	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius