Duns Number:097664937
Device Description: The Modulare System is used to secure various types of catheters to the patient’s skin. Th 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.
Catalog Number
-
Brand Name
Modulare Stabilization Device
Version/Model Number
M-CVC/PICC
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 17, 2019
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KMK
Product Code Name
Device, Intravascular Catheter Securement
Public Device Record Key
3352f65c-9e29-4344-acbe-6b57b9a58ced
Public Version Date
July 20, 2020
Public Version Number
7
DI Record Publish Date
March 16, 2015
Package DI Number
00013964672213
Quantity per Package
120
Contains DI Package
00013964672077
Package Discontinue Date
December 17, 2019
Package Status
Not in Commercial Distribution
Package Type
Shipper Box 20 Packs
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |