AccessGUDID - DEVICE: SafeBreak - Vascular (10860635000311)

GUDID

Device Identifier (DI) Information

Brand Name: SafeBreak - Vascular
Version or Model: A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2855-01-0001
Company Name: Lineus Medical

Primary DI Number: 10860635000311
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081269269 *Terms of Use

Device Description: SafeBreak Vascular is a Force-Activated Separation Device. It is intended to separate when excessive tension is exerted across a peripheral IV administration set. When SafeBreak Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient’s IV catheter. SafeBreak Vascular is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. SafeBreak Vascular is intended to be used on peripheral IV catheters in adults and adolescent populations eighteen (18) years of age and older receiving intermittent or continuous infusions with an electronic pump.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
66263	Luer/Luer breakaway connector	A small, non-powered, noninvasive, linear Luer connector intended to connect between a percutaneous catheter (e.g., intravenous (IV) catheter, nephrostomy catheter) and external tubing (e.g., drainage tubing, IV line) to facilitate safe disconnection if excessive tension is placed on the catheter or tubing (e.g., unintentional tugging or pulling). The safe disconnection feature/force activated separation mechanism is designed to reduce patient injury and includes valves to prevent fluid loss and contamination. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QOI	Intravenous Catheter Force-Activated Separation Device.

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN190043	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 6d68c13a-9967-417b-b8bf-4d1d8cb2b08a
Public Version Date: February 06, 2025
Public Version Number: 2
DI Record Publish Date: June 20, 2022