Tru-Fix Catheter Fixation Kit TFK-10

GUDID 10817640020667

Tru-Fix Catheter Fixation Kit - 10F

URESIL, LLC

Wearable percutaneous catheter/tube holder
Primary Device ID10817640020667
NIH Device Record Key168c1aa9-dff6-416c-9a0c-becc661cc5a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTru-Fix Catheter Fixation Kit
Version Model NumberTFK-10
Catalog NumberTFK-10
Company DUNS192559557
Company NameURESIL, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com
Phone1-800-538-7374
Emailsales@uresil.com

Device Dimensions

Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100817640020660 [Primary]
GS110817640020667 [Package]
Contains: 00817640020660
Package: Dispenser [5 Units]
In Commercial Distribution
GS120817640020664 [Package]
Package: Shipper [5 Units]
In Commercial Distribution
HIBCCH862TFK100 [Previous]

FDA Product Code

KGXTape And Bandage, Adhesive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-20
Device Publish Date2022-05-12

On-Brand Devices [Tru-Fix Catheter Fixation Kit]

H862TFK162Tru-Fix Catheter Fixation Kit - 16F
H862TFK142Tru-Fix Catheter Fixation Kit - 14F
H862TFK122Tru-Fix Catheter Fixation Kit - 12F
H862TFK102Tru-Fix Catheter Fixation Kit - 10F
H862TFK082Tru-Fix Catheter Fixation Kit - 8F
H862TFK062Tru-Fix Catheter Fixation Kit - 6F
H862TFDR2Tru-Fix Fixation Dressing Replacement
10817640020698Tru-Fix Catheter Fixation Kit - 16F
10817640020681Tru-Fix Catheter Fixation Kit - 14F
10817640020674Tru-Fix Catheter Fixation Kit - 12F
10817640020667Tru-Fix Catheter Fixation Kit - 10F
10817640020650Tru-Fix Catheter Fixation Kit - 8F
10817640020643Tru-Fix Catheter Fixation Kit - 6F
10817640020636Tru-Fix Fixation Dressing Replacement

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