FDA.report

Jazzy Passport

Primary DI
00606509100212
Brand
Jazzy Passport
Company
PRIDE MOBILITY PRODUCTS CORPORATION
Model
Jazzy Passport
Catalog number
N/A
Device description
A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Published
2017-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ITIWheelchair, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00606509100212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00606509100212006065091002126065091002120606509100212

GMDN Terms

TermDefinition
Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsibleA wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be propelled by power from one or more electric motor(s). The electronic control of speed and direction may be performed by an attendant or the occupant. The device may be disassembled or folded for transport.

Sterilization Methods

Method

Regulatory Flags

DUNS number
041477449
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00606509500234MM3710MM3710N/A2022-07-22
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00606509100298EVO614EVO614N/A2022-01-04
00606509100304EVO614HDEVO614HDN/A2022-01-04
00606509300612CX3CX3N/A2022-01-04
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