Infyna Chic

GUDID 00610075072682

Hydrophilic, single-use intermittent catheter

HOLLISTER INCORPORATED

Single-administration urethral drainage catheter
Primary Device ID00610075072682
NIH Device Record Key74543485-9623-4375-9bbd-0809d4f2c587
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfyna Chic
Version Model Number8110-30
Company DUNS005527098
Company NameHOLLISTER INCORPORATED
Device Count30
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)323-4060
Emailccsecurestart@hollister.com
Phone+1(800)323-4060
Emailccsecurestart@hollister.com
Phone+1(800)323-4060
Emailccsecurestart@hollister.com
Phone+1(800)323-4060
Emailccsecurestart@hollister.com
Phone+1(800)323-4060
Emailccsecurestart@hollister.com
Phone+1(800)323-4060
Emailccsecurestart@hollister.com
Phone+1(800)323-4060
Emailccsecurestart@hollister.com
Phone+1(800)323-4060
Emailccsecurestart@hollister.com
Phone+1(800)323-4060
Emailccsecurestart@hollister.com
Phone+1(800)323-4060
Emailccsecurestart@hollister.com
Phone+1(800)323-4060
Emailccsecurestart@hollister.com
Phone+1(800)323-4060
Emailccsecurestart@hollister.com
Phone+1(800)323-4060
Emailccsecurestart@hollister.com
Phone+1(800)323-4060
Emailccsecurestart@hollister.com
Phone+1(800)323-4060
Emailccsecurestart@hollister.com

Device Dimensions

Catheter Length5 Inch
Catheter Gauge10 French
Catheter Length5 Inch
Catheter Gauge10 French
Catheter Length5 Inch
Catheter Gauge10 French
Catheter Length5 Inch
Catheter Gauge10 French
Catheter Length5 Inch
Catheter Gauge10 French
Catheter Length5 Inch
Catheter Gauge10 French
Catheter Length5 Inch
Catheter Gauge10 French
Catheter Length5 Inch
Catheter Gauge10 French
Catheter Length5 Inch
Catheter Gauge10 French
Catheter Length5 Inch
Catheter Gauge10 French
Catheter Length5 Inch
Catheter Gauge10 French
Catheter Length5 Inch
Catheter Gauge10 French
Catheter Length5 Inch
Catheter Gauge10 French
Catheter Length5 Inch
Catheter Gauge10 French
Catheter Length5 Inch
Catheter Gauge10 French

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100610075072651 [Primary]
GS100610075072682 [Unit of Use]
GS110610075072658 [Package]
Contains: 00610075072651
Package: Case [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GBMCatheter, Urethral

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-09
Device Publish Date2021-02-01

On-Brand Devices [Infyna Chic]

00610075072712Hydrophilic, single-use intermittent catheter
00610075072705Hydrophilic, single-use intermittent catheter
00610075072682Hydrophilic, single-use intermittent catheter
00610075072644Hydrophilic, single-use intermittent catheter
00610075072699Hydrophilic, single-use intermittent catheter

Trademark Results [Infyna Chic]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INFYNA CHIC
INFYNA CHIC
88478368 not registered Live/Pending
Hollister Incorporated
2019-06-18

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