AccessGUDID - DEVICE: Modulare Stabilization Device (00013964672237)

GUDID

Device Identifier (DI) Information

Brand Name: Modulare Stabilization Device
Version or Model: M-CVC/PICCSP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: INSIGHTRA MEDICAL, INC.

Primary DI Number: 00013964672237
Issuing Agency: GS1
Commercial Distribution End Date: December 05, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 097664937 *Terms of Use

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

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KMK	Device, Intravascular Catheter Securement

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c43b30f8-2b06-4729-b5b9-9ad3cb2fff30
Public Version Date: July 20, 2020
Public Version Number: 7
DI Record Publish Date: March 16, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00013964672275	300	00013964672237	2019-12-05	Not in Commercial Distribution	Shipper Box 50 Packs
00013964672268	120	00013964672237	2019-12-05	Not in Commercial Distribution	Shipper Box 20 Packs
00013964672251	50	00013964672237	2019-12-05	Not in Commercial Distribution	Unit Carton 50 Pack
00013964672244	20	00013964672237	2019-12-05	Not in Commercial Distribution	Unit Carton 20 Pack