AccessGUDID - DEVICE: Traxx Mobility Systems (00850056676014)

GUDID

Device Identifier (DI) Information

Brand Name: Traxx Mobility Systems
Version or Model: Titan 500
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Traxx Mobility Systems LLC

Primary DI Number: 00850056676014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 025612885 *Terms of Use

Device Description: 10-foot-wide freestanding patient lift system

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):	Yes
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?
30021	Freestanding patient lifting system, electrically-powered	An electrically-powered, stationary (non-mobile) assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort within an area limited by the lifting radius of the system. Also known as a patient hoist, it typically consists of a support base (non-fixed and freestanding on the floor) with a motorized lifting mechanism, mast, boom/lifting arm(s), swivel bar, and patient holding device (e.g., a sling, holder or a frame). Repositioning of the assembly may be achieved by lifting it to a new position/location.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSA	Lift, patient, non-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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: db3c33a3-9e82-4fc1-8537-9cac9442aeb9
Public Version Date: November 03, 2023
Public Version Number: 1
DI Record Publish Date: October 26, 2023

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(734)744-8100
Email: colson@traxxms.com

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