FDA.reportPublic FDA data

Bio Centric Inc

Primary DI
08600054858002
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
New
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
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
08600054858002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08600054858002086000548580028600054858002

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
00860005485802Bio Centric IncBP900SiM2020-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860005485802Bio 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