FDA.reportPublic FDA data

Dover

Primary DI
20884521029559
Brand
Dover
Company
Cardinal Health, Inc.
Model
7946
Catalog number
7946
Device description
Urine Foley Tray
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
GBMCATHETER, URETHRAL
PPBFoley Catheter Kit (Excludes Hiv Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBMCatheter, UrethralGastroenterology, Urology2
PPBFoley Catheter Kit (Excludes Hiv Testing)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521029559PackageGS110In Commercial Distribution
10884521029552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452102955920884521029559
1088452102955210884521029552

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral catheterization kit, adultA collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French

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
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884527009954Kendall30781747307817472018-06-23
30884527004748Kendall5000736150007361-2016-09-24
10884521021105MonojectSC5008XSC5008X2016-10-20
10884521021112MonojectSC6011XSC6011X2016-10-20
20884521152066Devon31145660311456602016-09-24
20884521152073Devon31145678311456782016-09-24
20884521152080Devon31145686311456862016-09-24
20884521152097Devon31145694311456942016-09-24
20884521152103Devon31145702311457022016-09-24
20884521152110Devon31145710311457102016-09-24
20884521152127Devon31145728311457282016-09-24
20884527020529Argyle888816035888881603582016-09-28
10884521000711Argyle888875001888887500182016-09-24
10884521000735Argyle888875051388887505132016-09-24
10884521011502Kangaroo888474121288847412122016-09-24
10884521011519Kangaroo888474121588847412152016-09-24
10884521011526Kangaroo888474122088847412202016-10-20
10884521011533Kangaroo888474122588847412252016-09-24
10884521011557Kangaroo888474123588847412352016-09-24
10884521011595Kangaroo888474164988847416492016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10610075097439OnliHOLLISTER INCORPORATEDGBM2026-02-01
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10610075097453OnliHOLLISTER INCORPORATEDGBM2026-02-01
20610075091922VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092585VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092592VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092608VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092615VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092622VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092639VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092646VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092653VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092660VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092677VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092684VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092691VaProHOLLISTER INCORPORATEDGBM2026-01-30
20610075092707VaProHOLLISTER INCORPORATEDGBM2026-01-30
50192253068199DoverCardinal Health 200, LLCPPB2026-01-15
50192253068205DoverCardinal Health 200, LLCPPB2026-01-15
40198459403096MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PPB2025-07-21
40198459407087MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PPB2025-07-07
40198459290320Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2025-03-16
40198459277710Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2025-03-02
20192253058434DoverCardinal Health 200, LLCGBM2025-01-23
20192253058441DoverCardinal Health 200, LLCGBM2025-01-23
20192253058458DoverCardinal Health 200, LLCGBM2025-01-23
20192253058465DoverCardinal Health 200, LLCGBM2025-01-23
20192253058472DoverCardinal Health 200, LLCGBM2025-01-23
20192253058489DoverCardinal Health 200, LLCGBM2025-01-23
20192253058496DoverCardinal Health 200, LLCGBM2025-01-23