Modulare Stabilization Device

GUDID 00013964672077

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 Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder
Primary Device ID00013964672077
NIH Device Record Key3352f65c-9e29-4344-acbe-6b57b9a58ced
Commercial Distribution Discontinuation2019-12-17
Commercial Distribution StatusNot in Commercial Distribution
Brand NameModulare Stabilization Device
Version Model NumberM-CVC/PICC
Company DUNS097664937
Company NameINSIGHTRA MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100013964672077 [Primary]
GS100013964672183 [Package]
Package: Unit Carton 50 Pack [50 Units]
Discontinued: 2019-12-17
Not in Commercial Distribution
GS100013964672206 [Package]
Package: Unit Carton 20 Pack [20 Units]
Discontinued: 2019-12-17
Not in Commercial Distribution
GS100013964672213 [Package]
Package: Shipper Box 20 Packs [120 Units]
Discontinued: 2019-12-17
Not in Commercial Distribution
GS100013964672220 [Package]
Package: Shipper Box 50 Packs [300 Units]
Discontinued: 2019-12-17
Not in Commercial Distribution

FDA Product Code

KMKDevice, Intravascular Catheter Securement

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-12-18
Device Publish Date2015-03-16

On-Brand Devices [Modulare Stabilization Device]

00013964672275The Modulare System is used to secure various types of catheters to the patient’s skin. The de
00013964672077The Modulare System is used to secure various types of catheters to the patient’s skin. The de
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.