Modulare Stabilization Device

Basic Information

• Brand Name: Modulare Stabilization Device
• Primary DI: 00013964672237
• Version / Model: M-CVC/PICCSP
• Company Name: INSIGHTRA MEDICAL, INC.
• Labeler DUNS: 097664937
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-03-16
• Public Version: 7
• Public Version Date: 2020-07-20
• Public Version Status: Update
• Public Device Record Key: c43b30f8-2b06-4729-b5b9-9ad3cb2fff30
• Distribution End Date: 2019-12-05

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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
KMK	Device, Intravascular Catheter Securement	General Hospital	880.5210	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56631	Wearable percutaneous catheter/tube holder	A device designed to fix a percutaneous catheter, tube, and/or drain (e.g., IV, epidural, or drainage catheter, GI tube) to a patient's body without suturing; it may additionally be intended for holding a non-surgically-invasive tube (e.g., nasogastric tube) to the patient (universal holder). It is designed as an adhesive pad, strip, or bandage that will attach to the patient's skin, sometimes with the exposed side having an integrated fixation mechanism (e.g., Velcro hook/loop closure) or a mechanical closure, to hold the catheter/tube in place. It may include a transparent film portion intended for fixation site monitoring. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00013964672275	GS1	Shipper Box 50 Packs	300	Not in Commercial Distribution	2019-12-05
Primary	00013964672237	GS1
Package	00013964672268	GS1	Shipper Box 20 Packs	120	Not in Commercial Distribution	2019-12-05
Package	00013964672251	GS1	Unit Carton 50 Pack	50	Not in Commercial Distribution	2019-12-05
Package	00013964672244	GS1	Unit Carton 20 Pack	20	Not in Commercial Distribution	2019-12-05

Customer Contacts

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