Sunmed

GUDID 20889483005610

2 Way Foley Catheter 5cc Balloon 22fr

SUNMED, LLC

Indwelling urethral drainage catheter
Primary Device ID20889483005610
NIH Device Record Keydef08b7c-89b5-41df-be93-20eade2b463a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSunmed
Version Model Number7-6515-22
Company DUNS069009268
Company NameSUNMED, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com
Phone800-433-2797
Emailinfo@sun-med.com

Device Dimensions

Catheter Gauge22 French
Catheter Gauge22 French
Catheter Gauge22 French
Catheter Gauge22 French
Catheter Gauge22 French
Catheter Gauge22 French
Catheter Gauge22 French
Catheter Gauge22 French
Catheter Gauge22 French
Catheter Gauge22 French
Catheter Gauge22 French
Catheter Gauge22 French
Catheter Gauge22 French
Catheter Gauge22 French
Catheter Gauge22 French
Catheter Gauge22 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *34917
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *34917
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *34917
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *34917
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *34917
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *34917
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *34917
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *34917
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *34917
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *34917
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *34917
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *34917
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *34917
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *34917
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *34917
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *34917
Handling Environment TemperatureBetween 0 Degrees Celsius and 49 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110889483005613 [Primary]
GS120889483005610 [Package]
Contains: 10889483005613
Package: box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZLCatheter, Retention Type, Balloon

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2018-09-24
Device Publish Date2016-10-05

On-Brand Devices [Sunmed]

10889483056523BATTERY COVER FOR SUNSTIM PLUS
10889483056516BATTERY COVER FOR SUNSTIM
10889483055564SUNSTIM PLUS OVERLAY
10889483055557SUNSTIM OVERLAY
20889483048105E/T TUBE CUFFED 2.5mm 10FR
10889483042250Opthalmoscope Lamp 2.5V
10889483042236Opthalmoscope Lamp 3.5V
10889483042212Opthalmoscope Lamp 3.5V
20889483041502TRACH TUBE CUFFED SZ 9.5mm
20889483041496TRACH TUBE CUFFED SZ 9.0mm
20889483041489TRACH TUBE CUFFED SZ 8.5mm
20889483041472TRACH TUBE CUFFED SZ 8.0mm
20889483041465TRACH TUBE CUFFED SZ 7.5mm
20889483041458TRACH TUBE CUFFED SZ 7.0mm
20889483041441TRACH TUBE CUFFED SZ 6.5mm
20889483041434TRACH TUBE CUFFED SZ 6.0mm
20889483041090REINFORCED E/T TUBE CUFFED 32FR
20889483041083REINFORCED E/T TUBE CUFFED 30FR
20889483041076REINFORCED E/T TUBE CUFFED 28FR
20889483041069REINFORCED E/T TUBE CUFFED 26FR
20889483041052REINFORCED E/T TUBE CUFFED 24FR
20889483041045REINFORCED E/T TUBE CUFFED 22FR
20889483041038REINFORCED E/T TUBE CUFFED 20FR
20889483041021REINFORCED E/T TUBE CUFFED 18FR
20889483041014REINFORCED E/T TUBE CUFFED 16FR
20889483041007REINFORCED E/T TUBED CUFFED 14FR
20889483040994REINFORCED E/T TUBE CUFFED 40FR
20889483040765E/T TUBE CUFFED W/STYLET 8.5mm 34FR
20889483040758E/T TUBE CUFFED W/STYLET 8.0mm 32FR
20889483040741E/T TUBE CUFFED W/STYLET 7.5mm 30FR
20889483040734E/T TUBE CUFFED W/STYLET 7.0mm 28FR
20889483040727E/T TUBE CUFFED W/STYLET 6.5mm 26FR
20889483040710E/T TUBE CUFFED W/STYLET 6.0mm 24FR
20889483040703E/T TUBE CUFFED W/STYLET 5.5mm 22FR
20889483040697E/T TUBE CUFFED W/STYLET 5.00mm 20FR
20889483040680E/T TUBE CUFFED W/STYLET 4.5mm 18FR
20889483040673E/T TUBE CUFFED W/STYLET 4.0mm 16FR
20889483040666E/T TUBE CUFFED W/STYLET 3.5mm 14FR
20889483040543E/T TUBE CUFFED 5.0mm 20FR
20889483040536E/T TUBE CUFFED 4.5mm 18FR
20889483040529E/T TUBE CUFFED 4.0mm 16FR
20889483040512E/T TUBE CUFFED 3.5mm 14FR
20889483040505E/T TUBE CUFFED 3.0mm 12FR
20889483040499E/T TUBE CUFFED 10.0mm 40FR
20889483040482E/T TUBE NO-CUFF 5.5mm 22FR
20889483040475E/T TUBE NO-CUFF 5.0mm 20FR
20889483040468E/T TUBE NO-CUFF 4.5mm 18FR
20889483040451E/T TUBE NO-CUFF 4.0mm 16FR
20889483040444E/T TUBE NO-CUFF 3.5mm 14FR
10889483039038PEEP VALVE 5-20cm 30mm ID X 33mm OD

Trademark Results [Sunmed]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SUNMED
SUNMED
98691527 not registered Live/Pending
Sunflora, Inc.
2024-08-09
SUNMED
SUNMED
98651416 not registered Live/Pending
Sunflora, Inc.
2024-07-16
SUNMED
SUNMED
90825611 not registered Live/Pending
Sunflora, Inc.
2021-07-13
SUNMED
SUNMED
90285710 not registered Live/Pending
Sunflora, Inc.
2020-10-29
SUNMED
SUNMED
88498224 not registered Live/Pending
Sunflora, Inc.
2019-07-02
SUNMED
SUNMED
85381420 4111672 Live/Registered
SunMed, LLC
2011-07-26
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