AccessGUDID - DEVICE: IntuBrite (00607411969676)

GUDID

Device Identifier (DI) Information

Brand Name: IntuBrite
Version or Model: 1021.C.2015.C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1021.C.2015.C
Company Name: SALTER LABS

Primary DI Number: 00607411969676
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022721133 *Terms of Use

Device Description: Mac 1/Medium SINGLE USE DISPSOABLE LARYNGOSCOPE SYSTEM. One disposable handle and one disposable blade.

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:	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?
46828	Laryngoscope blade, single-use	The segment of a laryngoscope (i.e., rigid intubation type) intended to be inserted into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It is connected to the laryngoscope handle and illumination of the airway is provided by a small built-in light bulb or a fibreoptic light. This device may be curved or straight and of various designs and lengths; it may be hinged/interchanged with the handle. Some types are magnetic resonance imaging (MRI) compatible. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCW	Laryngoscope, Rigid

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: 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: 014931ce-eef1-4220-8ab0-5c6cda632105
Public Version Date: March 26, 2019
Public Version Number: 1
DI Record Publish Date: March 18, 2019