FDA.reportPublic FDA data

Dover

Primary DI
10884521016576
Brand
Dover
Company
Cardinal Health, Inc.
Model
6108
Catalog number
6108
Device description
100% Silicone Foley Catheter,3 mL, 2-Way, Luer-Lock Adapter
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KODCATHETER, UROLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KODCatheter, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K921054000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K921054000KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH.Kendall Healthcare Products Co. Div.Of Tyco Health1992-09-23KOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521016573PackageGS112In Commercial Distribution
30884521016570PackageGS1120In Commercial Distribution
10884521016576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452101657320884521016573
3088452101657030884521016570
1088452101657610884521016576

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral drainage balloon catheter, non-antimicrobialA flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge18French
Length50Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Contacts#

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

Regulatory Flags#

DUNS number
080935429
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30884527016048Devon31145942311459422018-06-29
10884521170728Kendall507250722016-09-24
10884527023240Kerlix258525852018-06-23
10884527023295Kerlix507250722018-06-30
10884521744585Kendall8608U8608U2017-09-07
10884521744608Kendall8617U8617U2017-09-07
10884521744622Kendall8618U8618U2017-09-07
20884521100432SharpSafety8608U8608U2016-09-24
20884521100463Monoject8617U8617U2016-09-24
20884521100470Monoject8618U8618U2016-09-24
40884521023100Monoject31142222311422222016-09-24
10884521020511Monoject888124713788812471372018-06-30
10884527019922Argyle888850200588885020052016-09-24
10884527019847Argyle888850102388885010232016-09-24
20884527000088Argyle888472450488847245042018-06-30
00884521144227Webcol16818168182018-06-22
10884521189652Monoject1186000444T1186000444T2016-09-24
10884527007110Argyle888816305588881630552016-09-24
20885380173537Curity7267G7267G2019-11-14
20885380173568Curity9024G9024G2019-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704926944RUSCHTELEFLEX INCORPORATEDKOD2026-08-25
14026704926951RUSCHTELEFLEX INCORPORATEDKOD2026-08-25
14026704926968RUSCHTELEFLEX INCORPORATEDKOD2026-08-25
14026704933843RUSCHTELEFLEX INCORPORATEDKOD2026-08-25
14026704925732RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925749RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925763RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925770RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925787RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925947RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
10192253031782DoverCardinal Health 200, LLCKOD2026-06-18
10192253024258DoverCardinal Health 200, LLCKOD2026-03-20
10192253024265DoverCardinal Health 200, LLCKOD2026-03-20
10192253024272DoverCardinal Health 200, LLCKOD2026-03-20
10192253024302DoverCardinal Health 200, LLCKOD2026-03-20
10192253067651DoverCardinal Health 200, LLCKOD2025-04-14
10192253067668DoverCardinal Health 200, LLCKOD2025-04-14
10192253067675DoverCardinal Health 200, LLCKOD2025-04-14
10192253030365DoverCardinal Health 200, LLCKOD2025-04-07
10192253066289DoverCardinal Health 200, LLCKOD2024-09-04
10192253066296DoverCardinal Health 200, LLCKOD2024-09-04
10192253066302DoverCardinal Health 200, LLCKOD2024-09-04
10192253066319DoverCardinal Health 200, LLCKOD2024-09-04
10192253066326DoverCardinal Health 200, LLCKOD2024-09-04
10192253066333DoverCardinal Health 200, LLCKOD2024-09-04
10192253066340DoverCardinal Health 200, LLCKOD2024-09-04
10192253066357DoverCardinal Health 200, LLCKOD2024-09-04
10192253066364DoverCardinal Health 200, LLCKOD2024-09-04
10192253066371DoverCardinal Health 200, LLCKOD2024-09-04
10192253066388DoverCardinal Health 200, LLCKOD2024-09-04