FDA.reportPublic FDA data

Bio Centric Inc

Primary DI
00860005485802
Brand
Bio Centric Inc
Company
BIO CENTRIC INC.
Model
BP900SiM
Device description
Cellular enabled Class II BP Monitor
Published
2020-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NPPReprocessed Blood Pressure Cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPPReprocessed Blood Pressure CuffCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005485802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005485802008600054858028600054858020860005485802

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

Contacts#

Phone, Email table
PhoneEmail
956-578-1732info@biocentric.health

Regulatory Flags#

DUNS number
117643897
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08600054858002Bio Centric IncBP900SiM2020-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08600054858002Bio Centric IncBIO CENTRIC INC.NPP2020-12-01
10817357022503Nova PlusHYGIA HEALTH SERVICES, INC.NPP2018-06-22
10817357022510Welch AllynHYGIA HEALTH SERVICES, INC.NPP2018-06-22
30817357022507Nova PlusHYGIA HEALTH SERVICES, INC.NPP2018-06-22
30817357022514Welch AllynHYGIA HEALTH SERVICES, INC.NPP2018-06-22
10817357022312Welch AllynHYGIA HEALTH SERVICES, INC.NPP2017-06-24
10817357022329CritikonHYGIA HEALTH SERVICES, INC.NPP2017-06-24
30817357022316Welch AllynHYGIA HEALTH SERVICES, INC.NPP2017-06-24
30817357022323CritikonHYGIA HEALTH SERVICES, INC.NPP2017-06-24
10817357022305CritikonHYGIA HEALTH SERVICES, INC.NPP2017-04-08
30817357022309CritikonHYGIA HEALTH SERVICES, INC.NPP2017-04-08
10817357022275MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-25
10817357022282Welch AllynHYGIA HEALTH SERVICES, INC.NPP2017-02-25
30817357022279MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-25
30817357022286Welch AllynHYGIA HEALTH SERVICES, INC.NPP2017-02-25
10817357022145MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04
10817357022206Cardinal HealthHYGIA HEALTH SERVICES, INC.NPP2017-02-04
10817357022213Cardinal HealthHYGIA HEALTH SERVICES, INC.NPP2017-02-04
10817357022220MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04
10817357022237MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04
10817357022244MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04
10817357022251MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04
10817357022268MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04
30817357022149MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04
30817357022200Cardinal HealthHYGIA HEALTH SERVICES, INC.NPP2017-02-04
30817357022217Cardinal HealthHYGIA HEALTH SERVICES, INC.NPP2017-02-04
30817357022224MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04
30817357022231MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04
30817357022248MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04
30817357022255MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04