FDA.reportPublic FDA data

QardioBase

Primary DI
00854894005173
Brand
QardioBase
Company
QARDIO, INC.
Model
B100
Catalog number
B100-IOW
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MNWAnalyzer, Body Composition

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNWAnalyzer, Body CompositionCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854894005170PackageGS14In Commercial Distribution
00854894005173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085489400517010854894005170
00854894005173008548940051738548940051730854894005173

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical body composition analyserAn electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080029958
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854894005418Qardio Pulse OximeterJPD-500FJPD-500F2021-01-13
00854894005340QardioArm2A200A2002023-06-19
00854894005357QardioArm2A200-ILA200-IL2023-06-19
10854894005347QardioArm2A200A2002023-06-19
10854894005354QardioArm2A200-ILA200-IL2023-06-19
00854894005395Qardio Pro Cellular Blood Pressure MonitorBP100-4GBP100-4G2021-11-29
10854894005392Qardio Pro Cellular Blood Pressure MonitorBP100-4GBP100-4G2021-11-29
10854894005415Qardio Pulse OximeterJPD-500FJPD-500F2021-01-13
00854894005425Qardio Forehead thermometerTD-1261TD-12612021-01-08
10854894005422Qardio Forehead thermometerTD-1261TD-12612021-01-08
00854894005005QardioArmA100A1002016-09-24
00854894005012QardioArmA100A100-IRY2016-09-24
00854894005029QardioArmA100A100-IEB2016-09-24
00854894005036QardioArmA100A100-ILR2016-09-24
00854894005043QardioArmA100A100-IIR2016-09-24
00854894005050QardioArmA100A100-IMB2016-09-24
00854894005067QardioArmA100A100-IGO2016-09-24
00854894005074QardioArmA100A100-CRY2016-09-24
00854894005081QardioArmA100A100-CEB2016-09-24
00854894005104QardioArmA100A100-CAW2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04904785198449Body Composition AnalyzerTANITA CORPORATIONMNW2025-10-24
04904785230491Body Composition AnalyzerTANITA CORPORATIONMNW2025-10-24
08809209592260InBodyInBody Co., Ltd.MNW2025-10-03
08809209592277InBodyInBody Co., Ltd.MNW2025-10-03
00077784049198TAYLORTAYLOR PRECISION PRODUCTS, INC.MNW2025-05-06
20077784049192TAYLORTAYLOR PRECISION PRODUCTS, INC.MNW2025-05-06
08809209590969InBodyInBody Co., Ltd.MNW2024-07-23
00074108499714ConairCONAIR CORPORATIONMNW2024-05-13
B322F0011ES-BC LD TECHNOLOGY, LLCMNW2024-03-05
00875011004121Weight GurusGreater GoodsMNW2024-02-22
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08809209590976InBodyInBody Co., Ltd.MNW2023-06-22
08809209591676InBodyInBody Co., Ltd.MNW2023-06-22
08809209591683InBodyInBody Co., Ltd.MNW2023-06-22
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