FDA.reportPublic FDA data

Sensica UO System

Primary DI
00801741218491
Brand
Sensica UO System
Company
C. R. Bard, Inc.
Model
SBTS1001E
Catalog number
SBTS1001E
Device description
Sensica UO System Temperature Monitor Module for Evaluation
Published
2021-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXSURINOMETER, ELECTRICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXSUrinometer, ElectricalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741218498PackageGS18In Commercial Distribution
00801741218491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174121849810801741218498
00801741218491008017412184918017412184910801741218491

GMDN Terms#

Term, Definition table
TermDefinition
Urine monitoring systemAn assembly of devices intended to automatically and continuously monitor and display a patient's urine output (urine flow/volume). The system typically consists of a battery-powered, portable monitor with controls, digital display, alarms, and memory; an electronic (e.g., optical) urine output sensor; and a disposable urine collection container. The system is typically used in situations where fluid and renal management are critical to patient treatment and care [e.g., during diuresis monitoring in the intensive care unit (ICU)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure83 KiloPascal103 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(844)823-5433BMD.CS.support@bd.com

Regulatory Flags#

DUNS number
016898496
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741050817Leg Bag1505071505072020-09-23
00801741076039Catheter Stabilization DeviceVFDSPVFDSP2020-09-22
00801741076053Catheter Stabilization DeviceVFDSSPVFDSSP2020-09-22
00801741076077Catheter Stabilization DeviceFOL0100FOL01002020-09-22
00801741076091Catheter Stabilization DeviceFOL0101FOL01012020-09-22
00801741076114Catheter Stabilization DeviceFOL0102FOL01022020-09-22
00801741076145Catheter Stabilization DeviceFOL0105FOL01052020-09-22
00801741127625Bard® Leg Bag Holders1501111501112016-08-10
00801741127632Bard® Leg Bag Holders1501211501212016-08-10
00801741127649Bard® Leg Bag Holders1501311501312016-08-10
00801741137419Bard® Wide Leg Bag Straps1621101621102018-02-06
00801741137426Bard® Wide Leg Bag Straps1622101622102018-02-06
00801741137433Bard® Wide Leg Bag Straps1623101623102018-02-06
00801741215902StatLock UrologicalSTATURO25STATURO252020-10-23
00801741231025PureWickPW300PCPW300PC2026-05-07
00801741234514PureWickPWA300HPWA300H2026-05-07
00801741225239Elyra708200170820012026-05-06
00801741225246Elyra708200270820022026-05-06
00801741231537PureWickPWKIT03HPWKIT03H2026-05-06
10801741239219PureWickPWF030KXSPWF030KXS2026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00801741218507SensicaC. R. Bard, Inc.EXS2021-09-29
10801741218504SensicaC. R. Bard, Inc.EXS2021-09-29
10801741218498Sensica UO SystemC. R. Bard, Inc.EXS2021-06-30
00801741215643Sensica UO SystemC. R. Bard, Inc.EXS2021-06-16
00801741215735Sensica UO SystemC. R. Bard, Inc.EXS2021-06-16
00801741215759Sensica UO SystemC. R. Bard, Inc.EXS2021-06-16
00801741215766Sensica UO SystemC. R. Bard, Inc.EXS2021-06-16
00801741215612Sensica UO SystemC. R. Bard, Inc.EXS2021-06-16
10801741215640Sensica UO SystemC. R. Bard, Inc.EXS2021-06-16
10801741215732Sensica UO SystemC. R. Bard, Inc.EXS2021-06-16
10801741215756Sensica UO SystemC. R. Bard, Inc.EXS2021-06-16
10801741215763Sensica UO SystemC. R. Bard, Inc.EXS2021-06-16
00801741215650Sensica UO SystemC. R. Bard, Inc.EXS2021-04-30
00801741215742Sensica UO SystemC. R. Bard, Inc.EXS2021-04-30
10801741215657Sensica UO SystemC. R. Bard, Inc.EXS2021-04-30
20801741215746Sensica UO SystemC. R. Bard, Inc.EXS2021-04-30
00801741215773Sensica UO SystemC. R. Bard, Inc.EXS2021-03-29
00801741219016Sensica UO SystemC. R. Bard, Inc.EXS2021-03-29
00854003008019SensicaADAPTEC MEDICAL DEVICES LLCEXS2019-09-05
00801741144660Bard® Dual Connector to 3.5mm Plug Monitor CableC. R. Bard, Inc.EXS2019-05-23
00854003008002Sensica UO ADAPTEC MEDICAL DEVICES LLCEXS2018-10-30
10854003008009Sensica UO ADAPTEC MEDICAL DEVICES LLCEXS2018-10-30
00801741137525Bard® CritiCore® Face ShieldC. R. Bard, Inc.EXS2017-08-23
00801741104947Bard® Uros™ Precision Urine Output and Temperature MonitorC. R. Bard, Inc.EXS2017-02-14
00801741080777Bard® CritiCore® MonitorC. R. Bard, Inc.EXS2016-09-11