UM40018

GUDID 20884521057774

100% Silicone Urine Meter Foley Tray,18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor

Cardinal Health, Inc.

Indwelling urethral catheterization kit
Primary Device ID20884521057774
NIH Device Record Key4dbd3c03-c00d-4380-9b89-b3e5aaa4d9c3
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberUM40018
Catalog NumberUM40018
Company DUNS080935429
Company NameCardinal Health, Inc.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Catheter Gauge18 French
Total Volume400 Milliliter
Catheter Gauge18 French
Total Volume400 Milliliter
Catheter Gauge18 French
Total Volume400 Milliliter
Catheter Gauge18 French
Total Volume400 Milliliter
Catheter Gauge18 French
Total Volume400 Milliliter
Catheter Gauge18 French
Total Volume400 Milliliter
Catheter Gauge18 French
Total Volume400 Milliliter
Catheter Gauge18 French
Total Volume400 Milliliter
Catheter Gauge18 French
Total Volume400 Milliliter
Catheter Gauge18 French
Total Volume400 Milliliter
Catheter Gauge18 French
Total Volume400 Milliliter
Catheter Gauge18 French
Total Volume400 Milliliter
Catheter Gauge18 French
Total Volume400 Milliliter
Catheter Gauge18 French
Total Volume400 Milliliter
Catheter Gauge18 French
Total Volume400 Milliliter
Catheter Gauge18 French
Total Volume400 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS120884521057774 [Primary]
GS130884521057771 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KODCATHETER, UROLOGICAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-02-15
Device Publish Date2016-09-24

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