AccessGUDID - DEVICE: FlexStep (05714420046238)

GUDID

Device Identifier (DI) Information

Brand Name: FlexStep
Version or Model: FlexStep V2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 104623
Company Name: Liftup A/S

Primary DI Number: 05714420046238
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 308619001 *Terms of Use

Device Description: FlexStep V2, 700, 2+2 steps, Indoor

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?
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
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: f4d50b5c-2f23-4841-8688-15c3048ea6b5
Public Version Date: December 27, 2018
Public Version Number: 1
DI Record Publish Date: November 26, 2018

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: +1 844 543 8878
Email: info@liftup.us

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