FDA.reportPublic FDA data

BIOS

Primary DI
10057475242012
Brand
BIOS
Company
Thermor Ltd
Model
BD201
Device description
Easy Read Blood Pressure Monitor
Published
2022-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10057475242012PackageGS12In Commercial Distribution
80057475242011PackageGS112In Commercial Distribution
00057475242015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747524201210057475242012
8005747524201180057475242011
00057475242015000574752420150574752420150057475242015

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, portable, arm/wristAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
246883458
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00057475032500BIOS DiagnosticsW2502026-01-19
00057475491505BIOS DiagnosticsNS1502026-01-19
20057475032504BIOS DiagnosticsW2502026-01-19
00057475242909BIOS DiagnosticsBD2902026-01-19
10057475491502BIOS DiagnosticsNS1502026-01-19
00057475820213BIOS LivingRL0212026-01-19
00057475220495BIOS Diagnostics220DI2023-09-20
00057475282493BIOS282DI2023-05-23
00057475282738BIOS LivingLH2732024-03-21
00057475282745BIOS LivingLH2742024-03-21
00057475561017BIOS LivingEP1012024-03-22
00057475561024BIOS LivingEP1022024-03-22
00057475561031BIOS LivingEP1032024-03-23
00057475561048BIOS LivingEP1042024-03-23
00057475561055BIOS LivingEP1052024-03-22
00057475561062BIOS LivingEP1062024-03-22
00057475561079BIOS LivingEP1072024-03-22
00057475561086BIOS LivingEP1082024-03-22
00057475561093BIOS LivingEP1092024-03-22
00057475561222BIOS LivingEP1222024-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845717012171TrackstarVERIDIAN HEALTHCARE LLCDXN2026-05-28
00845717015509SmartHeartVERIDIAN HEALTHCARE LLCDXN2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
08800096401772Auto Blood Pressure MeterSEERS.Co.,LtdDXN2026-05-13
10850047516036KismeTruth Remote Patient MonitoringRemote Smart Health, LLCDXN2026-03-26
10840935111580Adult Orbit-K Cuff with Microphone, Bayonet, Reverse OrientationSUNTECH MEDICAL, INC.DXN2025-09-10
10840935111597Adult Plus Orbit-K Cuff with Microphone, Bayonet, Reverse OrientationSUNTECH MEDICAL, INC.DXN2025-09-10
10840935111603Large Adult Orbit-K Cuff with Microphone, Bayonet, Reverse OrientationSUNTECH MEDICAL, INC.DXN2025-09-10
08690020003017VitalScan ANSMedeia, Inc.DXN2025-02-05
10884450360634Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2024-09-06