FDA.reportPublic FDA data

Sensica UO

Primary DI
00854003008002
Brand
Sensica UO
Company
ADAPTEC MEDICAL DEVICES LLC
Model
SCCS-1001
Catalog number
1-005-0040
Device description
Automated urine meter system for continuous monitoring of urine output
Published
2018-10-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
10854003008009PackageGS11Not in Commercial Distribution
00854003008002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085400300800910854003008009
00854003008002008540030080028540030080020854003008002

GMDN Terms#

Term, Definition table
TermDefinition
Stand-on floor scale, electronicAn electrically-powered device designed to be placed on/integrated into the floor and upon which a patient is intended to stand to measure and display total body weight. It is not designed to weigh a wheelchair-bound patient or bed/stretcher.

Regulatory Flags#

DUNS number
090250920
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854003008019SensicaSSPK-10012019-09-05
10854003008009Sensica UO SCCS-10011-005-00402018-10-30

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
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
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