AccessGUDID - DEVICE: Vado (00810591020222)

GUDID

Device Identifier (DI) Information

Brand Name: Vado
Version or Model: SS8FMB74
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SS8FMB74
Company Name: KALILA MEDICAL, INC.

Primary DI Number: 00810591020222
Issuing Agency: GS1
Commercial Distribution End Date: October 01, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 015986592 *Terms of Use

Device Description: Steerable Sheath, Bidirectional

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:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Haemostasis valve	A sterile, noninvasive device with a self-sealing lumen (valve) designed as a conduit through which a small diameter diagnostic/interventional device (e.g., 25 French or less) can be introduced into or withdrawn from the patient's vasculature while maintaining haemostasis to reduce blood loss from the patient. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer, torque device). This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Haemostasis valve

A sterile, noninvasive device with a self-sealing lumen (valve) designed as a conduit through which a small diameter diagnostic/interventional device (e.g., 25 French or less) can be introduced into or withdrawn from the patient's vasculature while maintaining haemostasis to reduce blood loss from the patient. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer, torque device). This is a single-use device.

FDA Product Code

[?]

Product Code	Product Code Name
DYB	INTRODUCER, CATHETER

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry
Storage Environment Temperature: less than 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 11b48a0a-61fb-4d1e-b950-b3700b3c29d6
Public Version Date: June 07, 2018
Public Version Number: 3
DI Record Publish Date: May 19, 2017