FDA.reportPublic FDA data

Sensica UO

Primary DI
10854003008009
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
10854003008009PackageGS11In 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
090250920
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
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
00854003008019SensicaSSPK-10012019-09-05
00854003008002Sensica 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
00854003008002Sensica 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