Home GUDID 10884521164260 Kendall
Primary DI 10884521164260
Brand Kendall
Company Cardinal Health, Inc.
Model 2076CAO
Catalog number 2076CAO
Device description Intrauterine Pressure Catheter;Simultaneous Amnioinfusion Capability
Published 2016-09-24
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 Product Codes# Code, Name table Code Name KXO MONITOR, PRESSURE, INTRAUTERINE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KXO Monitor, Pressure, Intrauterine Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10884521164260 Package GS1 10 In Commercial Distribution 20884521164267 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10884521164260 10884521164260 20884521164267 20884521164267
GMDN Terms# Term, Definition table Term Definition Intrapartum pressure monitoring catheter A 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 Type Low High Condition Special Storage Condition, Specify 0 0 Keep dry;AVOID DIRECT SUNLIGHT
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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10884521643604 Kendall Cardinal Health, Inc. KXO 2018-05-26 10884521725492 Kendall Cardinal Health, Inc. KXO 2017-05-24 20884521725499 Kendall Cardinal Health, Inc. KXO 2017-05-24 20884521164267 Kendall Cardinal Health, Inc. KXO 2016-09-24 30884527004908 Kendall Cardinal Health, Inc. KXO 2016-09-24 10884521643611 Kendall Cardinal Health, Inc. KXO 2016-09-24 10884521643628 Kendall Cardinal Health, Inc. KXO 2016-09-24 20884527004901 Kendall Cardinal Health, Inc. KXO 2016-09-24 H671IUP0750 N/A UTAH MEDICAL PRODUCTS, INC. KXO 2016-09-23 H671IUP0751 N/A UTAH MEDICAL PRODUCTS, INC. KXO 2016-09-23
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