FDA.report

Detecto

Primary DI
00809161306705
Brand
Detecto
Company
CARDINAL SCALE MANUFACTURING COMPANY
Model
6500KGEU-VER
Device description
OIML EC Class III 300 kg x 0.1 kg, Portable Wheelchair Scale,Verified
Published
2019-05-10
Public version status
New
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

Product Codes

CodeName
INFScale, Platform, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
INFScale, Platform, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00809161306705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00809161306705008091613067058091613067050809161306705

GMDN Terms

TermDefinition
Wheelchair-accessible platform scaleAn electronic device designed to measure the weight of a wheelchair occupant who is unable to vacate their wheelchair; it may in addition be intended to function as a patient stand-on scale. It is designed as a floor-standing or floor-integrated platform whereby the known weight of the wheelchair is subtracted from the total measured weight to provide the weight of the wheelchair occupant; it is not designed to weigh a bed/stretcher.

Sterilization Methods

Method

Regulatory Flags

DUNS number
007153505
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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