AccessGUDID - DEVICE: TotalExam® Lite & Oto 2.0 (00850033167047)

GUDID

Device Identifier (DI) Information

Brand Name: TotalExam® Lite & Oto 2.0
Version or Model: GMD5505HD20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GMD5505HD20
Company Name: Globalmed Holdings, LLC

Primary DI Number: 00850033167047
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103201849 *Terms of Use

Device Description: TotalExam® Lite & Oto 2.0 Camera Kit, Includes General Exam and Otoscope.

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):	No
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?
58857	Multi-purpose digital medical camera	An electrically-powered, hand-held digital electro-optical device designed to capture video or still image data for multiple medical applications (e.g., ophthalmoscopic, otoscopic, and dermatoscopic) using dedicated interchangeable lenses/attachments. It typically consists of a lightproof chamber with an aperture fitted with a lens and a shutter, through which the image of an object is projected onto a surface for recording. It may include a user display screen for visualization before image capture, and sometimes a docking cradle for battery recharging and connection to a personal computer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZF	Device, Medical Examination, Ac Powered

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 -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0262faf4-558b-41fc-afc5-33a19e1b7b31
Public Version Date: December 24, 2024
Public Version Number: 2
DI Record Publish Date: August 04, 2023