Dover

Primary DI
20884521007816
Brand
Dover
Company
Cardinal Health, Inc.
Model
1600
Catalog number
1600
Device description
Catheter Plug with Cap
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951488000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951488000KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAPThe Kendal Co.1995-04-25KNY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521007816PackageGS150In 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, 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 will typically be pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass]. The device may be male or female dedicated. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
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
10884521000308Dover20042004-2016-09-24
10884521000681Dover202020202016-09-24
10884521001039Dover20142014-2016-09-24
10884521001053Dover20182018-2016-09-24
10884521001084Dover625662562016-09-24
10884521009455Dover34203420-2016-09-24
10884521009585Dover3450LF3450LF2016-09-24
10884521082403Curity260026002018-06-29
10884521084216Kerlix26719267192018-06-29
10884521158863Kendall2419CD2419CD2018-06-28
10884527020782Curity260126012018-06-29
10884521174917Devon31141206311412062016-09-24
10884527009954Kendall30781747307817472018-06-23
10884521015791Dover888762312588876231252016-09-24
30884527004847KendallES82417ES82417-2016-09-24
20884521152134Covidien3114574431145744-2016-09-24
30884521024841Kendall923692362018-06-30
10884521138247Devon31146891311468912016-09-24
10884521138261Devon31146893311468932016-09-24
10884521154094Devon31146894311468942016-09-24

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