FDA.reportPublic FDA data

QardioBase 2

Primary DI
10854894005248
Brand
QardioBase 2
Company
QARDIO, INC.
Model
B200
Catalog number
B200-IAW
Published
2017-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUHAnalyzer, Body Composition, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUHAnalyzer, Body Composition, ExemptCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854894005248PackageGS14In Commercial Distribution
00854894005241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085489400524810854894005248
00854894005241008548940052418548940052410854894005241

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

Contacts#

Phone, Email table
PhoneEmail
855 240 7323support@getqardio.com

Regulatory Flags#

DUNS number
080029958
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 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
04012030024921seca analytics 125seca GmbH & Co. KGPUH2026-06-02
06932825306118TeleRPMGuangdong Transtek Medical Electronics Co.,LtdPUH2026-05-29
06932825306125PulseGuangdong Transtek Medical Electronics Co.,LtdPUH2026-05-29
04719846013230CharderCHARDER ELECTRONIC CO., LTD.PUH2026-04-29
04719846016491CharderCHARDER ELECTRONIC CO., LTD.PUH2026-04-29
00810140063007RENPHOJoicom CorporationPUH2026-04-20
00810140062994RENPHOJoicom CorporationPUH2026-04-08
16977035520005ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520012ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520029ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520036ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
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16977035520159ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520166ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520173ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520180ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520197ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
00694501143849Health O MeterStar Elite IncPUH2026-03-25
00694501143863Health O MeterStar Elite IncPUH2026-03-25
00810140062901RENPHOJoicom CorporationPUH2026-01-04