AccessGUDID - DEVICE: HIGHLANDER (00817650021237)

GUDID

Device Identifier (DI) Information

Brand Name: HIGHLANDER
Version or Model: CPL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FLC0400SACI
Company Name: Harmar Summit, LLC

Primary DI Number: 00817650021237
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 144008062 *Terms of Use

Device Description: FREEDOM COMMERCIAL PLATFORM LIFT, 400 STANDARD, AC, INSIDE

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?
30036	Assistive passenger lift	An elevator designed to be used and operated by a person with a disability and to accommodate their assistive devices (e.g., a wheelchair) which move in a vertically shaft (up and down) to provide a method of transport between two or more vertical levels (e.g., floors in a building and ship decks).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ING	Elevator, wheelchair, portable

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: ae539a3e-3fad-4ad1-9a62-a97a611aa8db
Public Version Date: April 19, 2023
Public Version Number: 3
DI Record Publish Date: September 28, 2016

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: +1(800)833-0478
Email: quality_team@harmar.com

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