Invisiport 4.4 Fr 2000

GUDID 00864144000209

Invisiport 4.4 Fr Convenience Kit Contents: Invisiport 4.4Fr Vascular Access Port with Catheter (Not made with natural rubber latex); Microaccess Tear-Away Introducer Set; MicroIntroducer needle; Microguidewire; 20 Gauge, 1.5 inch, Non-Coring Access Needle

STEALTH THERAPEUTICS, INC.

Catheter injection port

• Primary Device ID: 00864144000209
• NIH Device Record Key: 244d1669-9655-4942-a22a-48ef8a836faa
• Commercial Distribution Discontinuation: 2018-09-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Invisiport 4.4 Fr
• Version Model Number: 2000
• Catalog Number: 2000
• Company DUNS: 963281709
• Company Name: STEALTH THERAPEUTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6082172685
• Email: customerservice@stealththerapeutics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864144000209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141146

FDA Product Code

• LJT: Port & Catheter, Implanted, Subcutaneous, Intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-27
• Device Publish Date: 2016-03-19