FDA.report

IDEA Health

Primary DI
G057IDWS8091
Brand
IDEA Health
Company
IDEA HEALTH LLC
Model
ID-WS809
Published
2021-04-08
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
FRIScale, Stand-On, Patient

Product Code Classifications

CodeDeviceSpecialtyClass
FRIScale, Stand-On, PatientGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G057IDWS8091PackageHIBCC1In Commercial Distribution
G057IDWS8092PackageHIBCC4In Commercial Distribution
G057IDWS8090PrimaryHIBCC0

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
117854485
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
G057IDBP8081IDEA HealthID-BP8082021-04-08

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