FDA.report

VANTAGE

Primary DI
00817650022111
Brand
VANTAGE
Company
HARMAR SUMMIT, LLC
Model
SL400
Catalog number
SL400LH
Device description
HARMAR - VANTAGE, LH
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
PCDPowered stairway chair lift

Product Code Classifications

CodeDeviceSpecialtyClass
PCDPowered Stairway Chair LiftPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817650022111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817650022111008176500221118176500221110817650022111

GMDN Terms

TermDefinition
Stairlift, chairA mains electricity (AC-powered) lifting device with an attached seating unit to accommodate a person with a disability, a geriatric or an infirm person to be transported up and down a staircase in a sitting position. 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 for home-use and in public venues and institutions.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
144008062
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00817650026317HighlanderVPLX600SRADCIVPLX0600SRADCI2025-06-12
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00817650026201PinnaclePinnacle, Rave, LeafSSL12012023-08-15
00817650026218PinnaclePinnacle, Rave, LeafSSL12022023-08-15
00817650024399RaveRave-IIRave-II-FR-LH2020-11-10
00817650024412RaveRave-IIRave-II-FR-RH2020-11-10
00817650024429RaveRave-IIRave-II-FR-RH-D2020-11-10
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