FDA.reportPublic FDA data

Detecto

Primary DI
00809161311808
Brand
Detecto
Company
CARDINAL SCALE MANUFACTURING COMPANY
Model
APEX-SH-S2E1-ACMUK
Device description
OIML EC Class III, 280kg x 0.1kg, apex Series Scale, Medical UK AC Adapter, Sonar Ht. Rod
Published
2022-09-16
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
00809161311808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00809161311808008091613118088091613118080809161311808

GMDN Terms#

Term, Definition table
TermDefinition
Stand-on floor scale, electronicAn electrically-powered device designed to be placed on/integrated into the floor and upon which a patient is intended to stand to measure and display total body weight. It is not designed to weigh a wheelchair-bound patient or bed/stretcher.

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
00809161326802Detecto8550-C-AC2022-09-16
00809161327007Detecto8550-C2022-09-16
00809161327205Detecto8550-AC2022-09-16
00809161327403Detecto8435-AC2022-09-16
00809161327502Detecto8432-CH-AC2022-09-16
00809161323603Detecto6856-C-AC2022-09-15

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