FDA.reportPublic FDA data

Kendall

Primary DI
10884521643611
Brand
Kendall
Company
Cardinal Health, Inc.
Model
56312
Catalog number
56312
Device description
Intrauterine Pressure Catheter Cable Fetal Monitor
Published
2016-09-24
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
KXOMONITOR, PRESSURE, INTRAUTERINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXOMonitor, Pressure, IntrauterineObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521643611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452164361110884521643611

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, interfacingA small unit dedicated to making communication possible between the patient monitoring system and other independent devices (e.g., ventilator, infusion pump, gas analyser, display monitors) connected to the same patient, creating an interface. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device) by providing connection between disparate devices. It may also be known as a medical information bus protocol.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No;

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080935429
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884527009954Kendall30781747307817472018-06-23
10884521015791Dover888762312588876231252016-09-24
30884527004847KendallES82417ES82417-2016-09-24
20884521152134Covidien3114574431145744-2016-09-24
30884521024841Kendall923692362018-06-30
10884521138247Devon31146891311468912016-09-24
10884521138261Devon31146893311468932016-09-24
10884521154094Devon31146894311468942016-09-24
10884521154100Devon31146895311468952016-09-24
10192253059984Dover7014MF7014MF2022-06-07
10884521013230Monoject888122524188812252412016-09-24
10884521013254Monoject888122524588812252452016-09-24
10884521024854Kendall923892382018-06-27
10884521004498Dover1455001455002016-09-24
10884521014091Monoject888150164088815016402016-09-24
10884521163041Magellan888185005888818500582016-09-24
10884527021932Uni-PatchEP84580EP845802016-09-24
20884521012216Monoject888153578888815357882016-09-24
20884521012254Monoject888156018288815601822016-09-24
20884521014159Monoject888151613588815161352016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521643604KendallCardinal Health, Inc.KXO2018-05-26
10884521725492KendallCardinal Health, Inc.KXO2017-05-24
20884521725499KendallCardinal Health, Inc.KXO2017-05-24
20884521164267KendallCardinal Health, Inc.KXO2016-09-24
30884527004908KendallCardinal Health, Inc.KXO2016-09-24
10884521643628KendallCardinal Health, Inc.KXO2016-09-24
10884521164260KendallCardinal Health, Inc.KXO2016-09-24
20884527004901KendallCardinal Health, Inc.KXO2016-09-24
H671IUP0750N/AUTAH MEDICAL PRODUCTS, INC.KXO2016-09-23
H671IUP0751N/AUTAH MEDICAL PRODUCTS, INC.KXO2016-09-23