Impella

Basic Information

• Brand Name: Impella
• Primary DI: 00813502011142
• Version / Model: 0046-3030
• Catalog Number: 0046-3030
• Company Name: Abiomed, Inc.
• Labeler DUNS: 050636737
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2014-07-31
• Public Version: 5
• Public Version Date: 2023-06-20
• Public Version Status: Update
• Public Device Record Key: 3b3cc4ab-1617-4b57-8ce4-2a7ca2310db8

Device Description

Packaged Slit Silicone Plugs (bx of 5)

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: Yes
• 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
OZD	Temporary Non-Roller Type Left Heart Support Blood Pump	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
31667	Catheter orifice occluder	A plug-like device intended to be inserted into a catheter (e.g., Foley catheter), or a catheter-like invasive device, to prevent flow through one or more orifice(s) in the catheter; it may also be referred to as a catheter spigot or catheter tip occluder. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813502011142	GS1
Unit of Use	00813502012088	GS1

Customer Contacts

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