Kendall

Primary DI
20884521725499
Brand
Kendall
Company
Cardinal Health, Inc.
Model
56300
Catalog number
56300
Device description
Intrauterine Pressure Catheter, Transducer Tipped, Dual Lumen
Published
2017-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
20884521725499PackageGS110In Commercial Distribution
10884521725492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452172549920884521725499
1088452172549210884521725492

GMDN Terms#

Term, Definition table
TermDefinition
Intrapartum pressure monitoring catheterA flexible tube with a pressure sensor, transducer, and/or thermistor located at its distal tip, used for intrapartum transcervical measurement of the intrauterine and amniotic pressures. It is attached at its proximal end via a signal cable to an external monitor that displays the pressure/temperature values, and is used to monitor the intensity, duration, and frequency of uterine contractions during labour. It may also be used for fluid infusion and sampling of amniotic fluid. It is typically made of plastic [e.g., polyethylene, polytetrafluoroethylene (PTFE) commonly known as Teflon, polyurethane] and/or silicone, and may include a catheter introducer/sheath. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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
20884521164267KendallCardinal Health, Inc.KXO2016-09-24
30884527004908KendallCardinal Health, Inc.KXO2016-09-24
10884521643611KendallCardinal 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