UM40016

GUDID 20884521174839

100% Silicone Urine Meter Foley Tray,16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor

Cardinal Health, Inc.

Indwelling urethral catheterization kit
Primary Device ID20884521174839
NIH Device Record Keyafd95fad-c081-4cfa-b3eb-58941901cb7d
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberUM40016
Catalog NumberUM40016
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 Gauge16 French
Total Volume400 Milliliter
Catheter Gauge16 French
Total Volume400 Milliliter
Catheter Gauge16 French
Total Volume400 Milliliter
Catheter Gauge16 French
Total Volume400 Milliliter
Catheter Gauge16 French
Total Volume400 Milliliter
Catheter Gauge16 French
Total Volume400 Milliliter
Catheter Gauge16 French
Total Volume400 Milliliter
Catheter Gauge16 French
Total Volume400 Milliliter
Catheter Gauge16 French
Total Volume400 Milliliter
Catheter Gauge16 French
Total Volume400 Milliliter
Catheter Gauge16 French
Total Volume400 Milliliter
Catheter Gauge16 French
Total Volume400 Milliliter
Catheter Gauge16 French
Total Volume400 Milliliter
Catheter Gauge16 French
Total Volume400 Milliliter
Catheter Gauge16 French
Total Volume400 Milliliter
Catheter Gauge16 French
Total Volume400 Milliliter

Operating and Storage Conditions

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
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing AgencyDevice ID
GS120884521174839 [Primary]
GS130884521174836 [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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