AxoTrack I Sterile Procedure Kit

Basic Information

• Brand Name: AxoTrack I Sterile Procedure Kit
• Primary DI: 00841517100162
• Version / Model: P22508-02
• Catalog Number: P22508
• Company Name: FUJIFILM SONOSITE, INC.
• Labeler DUNS: 014438860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-10
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d9d13159-8ccf-44dc-87c3-64e3f5dab2d4

Device Description

Diagnostic Ultrasound System Accessory. Sterile needle guidance kit to be used with P11x ultrasound transducer.

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: 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: 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
IYO	System, imaging, pulsed echo, ultrasonic	Radiology	892.1560	2
ITX	Transducer, ultrasonic, diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60443	Ultrasound/electromagnetic-guided needle kit	A collection of sterile devices intended to be used during a needle entry procedure (e.g., central venous access, aspiration of pneumothorax) that combines ultrasonic and electromagnetic methods for needle guidance (e.g., needle depth data using Hall effect sensors virtually overlaid on ultrasound imaging). It typically includes the needle/cannula with a magnetic attachment, coupling gel, and casing intended to provide a sterile shield for a separate, compatible ultrasound/electromagnetic transducer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841517100162	GS1
Package	30841517100163	GS1	case	10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K113680	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	21	Gauge

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Shelf Life = 36 months
• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius