AccessGUDID - DEVICE: SALINE LOCK KIT (M68980110050)

GUDID

Device Identifier (DI) Information

Brand Name: SALINE LOCK KIT
Version or Model: 05
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 80-110
Company Name: Safeguard US Operating, LLC

Primary DI Number: M68980110050
Issuing Agency: HIBCC
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 118492643 *Terms of Use

Device Description: 18 GA Catheter 1 ea 20 GA Catheter 1 ea Saline Flush (5cc pre-filled syringe) 1 ea Povidone Prep Pad 1 ea Alcohol Prep Pad 2 ea Needle Free Valve with Luer Lock 1 ea Constricting Band 1 ea Transparent Film Dressing 1 ea 2"x2" Gauze Pad (2 pack) 1 ea

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
62389	Wound irrigation cannula	A rigid or semi-rigid tube intended to be connected to a parent device (e.g., syringe) to channel irrigation fluids (e.g., saline solution) to a skin or surgical wound for washing and removing debris; it is not intended for aspiration of fluids. This is a single-use device intended to be used in a sterile condition.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRS	I.V. Start Kit

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 1d8d6355-4d91-4b1b-8237-ad5003de7180
Public Version Date: November 01, 2024
Public Version Number: 5
DI Record Publish Date: October 18, 2019