FDA.reportPublic FDA data

Dover

Primary DI
50192253027646
Brand
Dover
Company
Cardinal Health 200, LLC
Model
1600
Catalog number
1600-
Device description
CATHETER PLUG WITH CAP
Published
2024-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
50192253027646PackageGS150In Commercial Distribution
10192253027648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225302764650192253027646
1019225302764810192253027648

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent urethral drainage catheter, non-antimicrobial, single-useA flexible or rigid tube designed for a single insertion into the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide urine drainage, typically for an individual who is physiologically incapable of voiding. 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] and is disposed of after use; it does not include an antimicrobial agent(s). The device may be male or female dedicated. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253032338DoverCardinal Health 200, LLCKNY2024-07-10
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
00821925027589VARI-PASS 10/12 Fr (3.3/4mm) x 54CMGyrus Acmi, Inc.KNY2017-05-11
10680651445787HalyardAvanos Medical, Inc.KNY2017-05-10
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
03700512983590BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 35cmPromeplaKNY2016-10-03
03700512983606BI-FLEX ACCESS SHEATH - 10 inner / 12 outer - Length 45cmPromeplaKNY2016-10-03
03700512983613BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 45cmPromeplaKNY2016-10-03
00821925035157UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035164UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035171UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035188UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035195UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035201UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035218UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035225UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035256UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035270UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035287UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035294UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035300UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
20884521007816DoverCardinal Health, Inc.KNY2016-09-24
10607915111660Acucise® Endopyelotomy SystemAPPLIED MEDICAL RESOURCES CORPORATIONKNY2016-09-24
04048551086025n.a.Karl Storz GmbH & Co. KGKNY2016-09-23
03700512985587RocaFlex Access Sheath & Dilation Catheter 10/12x35cmPromeplaKNY2016-09-14