Cephus Catheter

GUDID 10860000559130

Sealcath, LLC

Barium enema catheter
Primary Device ID10860000559130
NIH Device Record Keye23d1b78-3fcb-455b-b15e-144cbff2a675
Commercial Distribution StatusIn Commercial Distribution
Brand NameCephus Catheter
Version Model Number0006560
Company DUNS079172500
Company NameSealcath, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
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

Phone+1(877)917-1453
Emailsupport@sealcath.com
Phone+1(877)917-1453
Emailsupport@sealcath.com
Phone+1(877)917-1453
Emailsupport@sealcath.com
Phone+1(877)917-1453
Emailsupport@sealcath.com
Phone+1(877)917-1453
Emailsupport@sealcath.com
Phone+1(877)917-1453
Emailsupport@sealcath.com
Phone+1(877)917-1453
Emailsupport@sealcath.com
Phone+1(877)917-1453
Emailsupport@sealcath.com
Phone+1(877)917-1453
Emailsupport@sealcath.com
Phone+1(877)917-1453
Emailsupport@sealcath.com
Phone+1(877)917-1453
Emailsupport@sealcath.com
Phone+1(877)917-1453
Emailsupport@sealcath.com
Phone+1(877)917-1453
Emailsupport@sealcath.com
Phone+1(877)917-1453
Emailsupport@sealcath.com
Phone+1(877)917-1453
Emailsupport@sealcath.com
Phone+1(877)917-1453
Emailsupport@sealcath.com
Phone+1(877)917-1453
Emailsupport@sealcath.com

Device Dimensions

Catheter Gauge30 French
Catheter Gauge30 French
Catheter Gauge30 French
Catheter Gauge30 French
Catheter Gauge30 French
Catheter Gauge30 French
Catheter Gauge30 French
Catheter Gauge30 French
Catheter Gauge30 French
Catheter Gauge30 French
Catheter Gauge30 French
Catheter Gauge30 French
Catheter Gauge30 French
Catheter Gauge30 French
Catheter Gauge30 French
Catheter Gauge30 French
Catheter Gauge30 French

Operating and Storage Conditions

Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 76 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 76 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100860000559133 [Primary]
GS110860000559130 [Package]
Contains: 00860000559133
Package: Box [10 Units]
In Commercial Distribution

FDA Product Code

FCEEnema kit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-07-22
Device Publish Date2018-11-30

On-Brand Devices [Cephus Catheter]

108600005591470006560
108600005591300006560
108600005591230006560
108600005591160006560
108600005591090006560

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