FDA.reportPublic FDA data

Sensica UO System

Primary DI
00801741215735
Brand
Sensica UO System
Company
C. R. Bard, Inc.
Model
STBM1025
Catalog number
STBM1025
Device description
Sensica Tube Band Positioning Strip - ICU
Published
2021-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
10801741215732PackageGS125In Commercial Distribution
20801741215739PackageGS18In Commercial Distribution
00801741215735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174121573210801741215732
2080174121573920801741215739
00801741215735008017412157358017412157350801741215735

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 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
Lot or batch
true
Expiration 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
00801741218491Sensica UO SystemC. R. Bard, Inc.EXS2021-06-30
10801741218498Sensica UO SystemC. R. Bard, Inc.EXS2021-06-30
00801741215643Sensica 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