AccessGUDID - DEVICE: Safe-Cam Display Monitor Charger (M710SCMR0)

GUDID

Device Identifier (DI) Information

Brand Name: Safe-Cam Display Monitor Charger
Version or Model: 033-6000-003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SC-MR
Company Name: BIOTEX, INC.

Primary DI Number: M710SCMR0
Issuing Agency: HIBCC
Commercial Distribution End Date: February 17, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 969792050 *Terms of Use

Device Description: No description.

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:	No
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?
62762	Rigid non-bladed intubation laryngoscope, video	A non-sterile device intended to facilitate the positioning of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It consists of a thin tubular portion inserted into the ET tube prior to intubation, with an electronic camera at its distal end to transmit anatomical images by a video system to a handle/monitor. It is typically made of memory-alloy material to allow moulding into a shape to facilitate intubation. This is a reusable 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
Storage Environment Temperature: between 0 and 35 Degrees Celsius
Storage Environment Humidity: between 10 and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 540 and 1060 millibar
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Handling Environment Humidity: between 25 and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 540 and 1060 millibar

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8261050f-86f2-49e3-b3a2-896aff63d12a
Public Version Date: March 06, 2025
Public Version Number: 3
DI Record Publish Date: July 25, 2018