Safari2

Basic Information

• Brand Name: Safari2
• Primary DI: 00816349012310
• Version / Model: SCMBW-014V
• Catalog Number: H74939706JPNL1
• Company Name: Lake Region Medical
• Labeler DUNS: 031108704
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-10
• Public Version: 2
• Public Version Date: 2020-07-01
• Public Version Status: Update
• Public Device Record Key: 6e190aba-3914-40d9-abb4-739a7c72ee57

Device Description

TAVR Guidewire

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQX	Wire, Guide, Catheter	Cardiovascular	870.1330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35094	Cardiac/peripheral vascular guidewire, single-use	A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10816349012317	GS1		5	In Commercial Distribution
Primary	00816349012310	GS1

Device Sizes

Type	Value	Unit	Text
Guidewire Length	275	Centimeter
Guidewire Diameter	.035	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry, dark place.