Elite HV®

Basic Information

• Brand Name: Elite HV®
• Primary DI: 04046964347764
• Version / Model: 612810
• Catalog Number: 612810
• Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC
• Labeler DUNS: 784259751
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-08-09
• Public Version: 6
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 3ff26dd2-5d65-4a5e-b26a-2b547a66acef

Device Description

8FR X 12CM ARTERIAL HEMO INTRO W/038 GW

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
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	04046964347764	GS1
Unit of Use	04046964347740	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K043525	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temp
• Type: Special Storage Condition, Specify