AccessGUDID - DEVICE: Incline Platform Lift (B24005)

GUDID

Device Identifier (DI) Information

Brand Name: Incline Platform Lift
Version or Model: 05
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Garaventa (Canada) Ltd.

Primary DI Number: B24005
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 252287586 *Terms of Use

Device Description: X3 - Permanently mounted wheelchair platform lift

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?
17817	Stairlift, platform	A mains electricity (AC-powered) device designed with a platform typically used to accommodate a user sitting in their wheelchair to be transported up and down a staircase. This electromechanical device is typically attached to one or more rails which follow the shape and angle of the staircase, but may be affixed in another manner. It will typically be installed in public venues, institutions, and for home-use.	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 [?]
K122206	000

Device Exempt from Premarket Submission: No 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: 590db7d4-7729-4890-b97d-c10d7fad1c3a
Public Version Date: April 04, 2024
Public Version Number: 4
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

[?]

No Customer Contact currently defined

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