OneCath Lubricated 2041-1614

GUDID 00852141007871

The OneCath Lubricated Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.

COMPACTCATH, INC.

Single-administration urethral catheterization kit, single-use
Primary Device ID00852141007871
NIH Device Record Key92c5d601-bb9b-43dc-be43-c325ebb23861
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneCath Lubricated
Version Model Number2041-1614
Catalog Number2041-1614
Company DUNS054765780
Company NameCOMPACTCATH, INC.
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (888) 933-2284
Emailsupport@compactcath.com
Phone+1 (888) 933-2284
Emailsupport@compactcath.com
Phone+1 (888) 933-2284
Emailsupport@compactcath.com
Phone+1 (888) 933-2284
Emailsupport@compactcath.com
Phone+1 (888) 933-2284
Emailsupport@compactcath.com
Phone+1 (888) 933-2284
Emailsupport@compactcath.com
Phone+1 (888) 933-2284
Emailsupport@compactcath.com
Phone+1 (888) 933-2284
Emailsupport@compactcath.com
Phone+1 (888) 933-2284
Emailsupport@compactcath.com
Phone+1 (888) 933-2284
Emailsupport@compactcath.com
Phone+1 (888) 933-2284
Emailsupport@compactcath.com
Phone+1 (888) 933-2284
Emailsupport@compactcath.com
Phone+1 (888) 933-2284
Emailsupport@compactcath.com
Phone+1 (888) 933-2284
Emailsupport@compactcath.com
Phone+1 (888) 933-2284
Emailsupport@compactcath.com
Phone+1 (888) 933-2284
Emailsupport@compactcath.com

Device Dimensions

Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French
Length16 Inch
Catheter Gauge14 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100852141007871 [Unit of Use]
GS100852141007925 [Primary]

FDA Product Code

EZDCatheter, Straight

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-04
Device Publish Date2021-09-25

On-Brand Devices [OneCath Lubricated]

00852141007895The OneCath Lubricated Intermittent Urinary Catheter is a sterile, single-use urine drainage cat
00852141007871The OneCath Lubricated Intermittent Urinary Catheter is a sterile, single-use urine drainage cat

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