AccessGUDID - DEVICE: Highlander (00817650023408)

GUDID

Device Identifier (DI) Information

Brand Name: Highlander
Version or Model: Highlander II
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VPL0600SCWACO
Company Name: Harmar Summit, LLC

Primary DI Number: 00817650023408
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 144008062 *Terms of Use

Device Description: Platform lift, 6 ft, Standard, commercial, hoistway, AC, outdoor

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?
17819	Wheelchair/occupant lift	A mains electricity (AC-powered) device designed for moving (lifting) a wheelchair and the seated occupant from one level to another to provide a means of vertical access. It typically consists of a platform, with no roof, onto which the patient wheels the wheelchair, using controls to move up or down; the lift does not move within a lift shaft. The lift is designed for use in buildings such as hospitals, homes, offices, and stores.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PCE	Permanently mounted wheelchair platform lift

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: 21d58a72-e34a-4401-bb9c-f818aed9c820
Public Version Date: April 19, 2023
Public Version Number: 2
DI Record Publish Date: December 20, 2019

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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