AccessGUDID - DEVICE: MTI (10840118439319)

GUDID

Device Identifier (DI) Information

Brand Name: MTI
Version or Model: 529W-001-80
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 529W-001-80
Company Name: Medical Technology Industries, Inc.

Primary DI Number: 10840118439319
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053947946 *Terms of Use

Device Description: 529W Podiatry/Wound Bariatric Chair, Std Base, 100-240V

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:	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?
38447	General examination/treatment chair, electric	A mains electricity (AC-powered) device designed to support and position the patient in a seated or reclined posture for easy access and patient comfort during a diagnostic examination, medical treatment, and/or surgical procedure across specialties. It usually has moveable components and may include special features such as a raising and lowering mechanism and removable arms; it may have an integrated weighing scale. For chairs involving the use of medical systems that emit and/or detect energy (e.g., ionizing or non-ionizing radiation, ultrasound, heat, light) see the respective chair terms for those systems.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBB	Chair, Surgical, 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
Handling Environment Temperature: between -10 and 50 Degrees Celsius
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 50 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c94c19f2-5141-4dd8-9f06-a0d49dceb09b
Public Version Date: May 03, 2022
Public Version Number: 1
DI Record Publish Date: April 25, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: (877) 875-4990
Email: technical.support@mti.net

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