FDA.reportPublic FDA data

Dover

Primary DI
10884521007819
Brand
Dover
Company
Cardinal Health 200, LLC
Model
1600
Catalog number
1600-
Device description
CATHETER PLUG WITH CAP
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNYACCESSORIES, CATHETER, G-U

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNYAccessories, Catheter, G-UGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521007816PackageGS150Not in Commercial Distribution
10884521007819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452100781620884521007816
1088452100781910884521007819

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent urethral drainage catheter, non-antimicrobial, reusableA flexible or rigid tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. Because of the potential frequency of catheterization, the device is typically pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass]; it does not include an antimicrobial agent(s). The device may be male or female dedicated. This is a reusable device.

Regulatory Flags#

DUNS number
961027315
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253015553T.E.D.399539952026-06-19
20192253016748Kendall22853228532021-05-19
20192253016755Kendall2285522855-2021-02-23
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253020240Kerlix332433242020-09-22
50192253020197Kerlix189218922020-08-12
50192253020357Kerlix673567352020-08-12
50192253020364Kerlix788278822020-08-12
50192253050422Devon31142931311429312023-07-10
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253027648DoverCardinal Health 200, LLCKNY2024-07-10
50192253032336DoverCardinal Health 200, LLCKNY2024-07-10
50192253027646DoverCardinal Health 200, LLCKNY2024-07-10
10192253032338DoverCardinal Health 200, LLCKNY2024-07-10
03700512966197Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10 Fr x 35cmPromeplaKNY2017-11-09
03700512966203Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cmPromeplaKNY2017-11-09
03700512966210Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cmPromeplaKNY2017-11-09
03700512966227Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cmPromeplaKNY2017-11-09
03700512986195Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10 Fr x 35cmPromeplaKNY2017-11-09
03700512986201Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cmPromeplaKNY2017-11-09
03700512986218Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cmPromeplaKNY2017-11-09
03700512986225Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cmPromeplaKNY2017-11-09
00821925036345VARI-PASSGyrus ACMI, LLCKNY2017-05-11
00821925027589VARI-PASS 10/12 Fr (3.3/4mm) x 54CMGyrus Acmi, Inc.KNY2017-05-11
10680651445787HalyardAvanos Medical, Inc.KNY2017-05-10
00821925035393UroPassGyrus ACMI, LLCKNY2016-10-12
00821925035409UroPass Gyrus ACMI, LLCKNY2016-10-12
00821925035423UroPassGyrus ACMI, LLCKNY2016-10-12
00821925005976UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-12
00821925005983UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-12
00821925005990UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-12
00821925035317UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035324GYRUS ACMI, INCGyrus ACMI, LLCKNY2016-10-03
00821925035331UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035348UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035355UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035362UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035379UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035386UroPassGyrus ACMI, LLCKNY2016-10-03
00821925035416UroPassGyrus ACMI, LLCKNY2016-10-03