FDA.reportPublic FDA data

Detecto

Primary DI
00809161309201
Brand
Detecto
Company
CARDINAL SCALE MANUFACTURING COMPANY
Model
6868KGEU-VER
Device description
OIML EC Class III 300 kg x 0.1 kg, Flip Seat w/Handrails,Veriified
Published
2019-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FRIScale, Stand-On, Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRIScale, Stand-On, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00809161309201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00809161309201008091613092018091613092010809161309201

GMDN Terms#

Term, Definition table
TermDefinition
Chair scale, electronicA battery-powered device designed for weighing elderly and/or weak patients, patients with a disability, or patients undergoing a specific treatment (e.g., dialysis) who are unable to use a conventional floor scale. It is the form of a chair in which the patient sits and their weight subsequently measured and displayed. It is primarily used for routine patient weight checks, but is also used to continuously and accurately monitor body fluid gain and loss in dialysis patients. It is designed to provide accurate patient weight measurements regardless of patient position in the chair seat.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007153505
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00809161336559Detecto20150912022-11-21
00809161336542Detecto20150902022-11-15
00809161339925Detecto20224992022-11-15
00809161340037Detecto20225102022-11-15
00809161346930Detecto6475-C-ACUK2022-11-04
00809161336221Detecto6800KGEU-C2022-10-19
00809161320503Detecto6880-C2022-09-19
00809161323108Detecto6880-C-AC2022-09-19
00809161335002Detecto6880-ACUK2022-09-19
00809161335309Direct Supply6880DS2022-09-19
00809161335408Direct Supply6880DS-AC2022-09-19
00809161335507Detecto6855MHR-AC-1K2022-09-19
00809161335606DetectoID-7236S-855RMP2022-09-19
00809161311501DetectoAPEX-SH-EU-AC2022-09-16
00809161311808DetectoAPEX-SH-S2E1-ACMUK2022-09-16
00809161326802Detecto8550-C-AC2022-09-16
00809161327007Detecto8550-C2022-09-16
00809161327205Detecto8550-AC2022-09-16
00809161327403Detecto8435-AC2022-09-16
00809161327502Detecto8432-CH-AC2022-09-16

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