Modulare Stabilization Device

GUDID 00013964672275

The Modulare System is used to secure various types of catheters to the patient’s skin. The device uses a post and securement cover to attach itself to either the suture tab of the catheter or mating hole on Modulare accessories. An adhesive base secures the Modulare system to the patient to allow for safe and secure placement of the catheter onto the patient. The Modulare system is disposable and designed to be placed on the patient for a time to not to exceed 7 days.

INSIGHTRA MEDICAL, INC.

Wearable percutaneous catheter/tube holder

• Primary Device ID: 00013964672275
• NIH Device Record Key: c43b30f8-2b06-4729-b5b9-9ad3cb2fff30
• Commercial Distribution Discontinuation: 2019-12-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Modulare Stabilization Device
• Version Model Number: M-CVC/PICCSP
• Company DUNS: 097664937
• Company Name: INSIGHTRA MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00013964672237 [Primary]
GS1	00013964672244 [Package]; Contains: 00013964672237; Package: Unit Carton 20 Pack [20 Units]; Discontinued: 2019-12-05; Not in Commercial Distribution
GS1	00013964672251 [Package]; Contains: 00013964672237; Package: Unit Carton 50 Pack [50 Units]; Discontinued: 2019-12-05; Not in Commercial Distribution
GS1	00013964672268 [Package]; Contains: 00013964672237; Package: Shipper Box 20 Packs [120 Units]; Discontinued: 2019-12-05; Not in Commercial Distribution
GS1	00013964672275 [Package]; Contains: 00013964672237; Package: Shipper Box 50 Packs [300 Units]; Discontinued: 2019-12-05; Not in Commercial Distribution

FDA Product Code

• KMK: Device, Intravascular Catheter Securement

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-12-06
• Device Publish Date: 2015-03-16

On-Brand Devices [Modulare Stabilization Device]

• 00013964672275: The Modulare System is used to secure various types of catheters to the patient’s skin. The de
• 00013964672077: The Modulare System is used to secure various types of catheters to the patient’s skin. The de