FDA.reportPublic FDA data

Dover

Primary DI
20884521008486
Brand
Dover
Company
Cardinal Health, Inc.
Model
7100
Catalog number
7100
Device description
Universal Catheterization Tray,Prepping Components
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
FCMTray, catheterization, sterile urethral, with or without catheter (kit)
PPCMale External Catheterization Kit (Excludes Hiv Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)Gastroenterology, Urology2
PPCMale External Catheterization Kit (Excludes Hiv Testing)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521008486PackageGS120In Commercial Distribution
10884521008489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452100848620884521008486
1088452100848910884521008489

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry;AVOID DIRECT SUNLIGHT
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
true
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
false
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
05708932778268SpeediCath Flex SetColoplast A/SFCM2026-02-05
50192253069547DoverCardinal Health 200, LLCFCM2026-01-20
50192253068533DoverCardinal Health 200, LLCFCM2026-01-16
50192253068540DoverCardinal Health 200, LLCFCM2026-01-16
50192253068557DoverCardinal Health 200, LLCFCM2026-01-16
50192253068564DoverCardinal Health 200, LLCFCM2026-01-16
50192253068571DoverCardinal Health 200, LLCFCM2026-01-16
50192253068588DoverCardinal Health 200, LLCFCM2026-01-16
50192253068595DoverCardinal Health 200, LLCFCM2026-01-16
50192253068618DoverCardinal Health 200, LLCFCM2026-01-16
50192253068663DoverCardinal Health 200, LLCFCM2026-01-16
50192253068700DoverCardinal Health 200, LLCFCM2026-01-16
50192253067956DoverCardinal Health 200, LLCFCM2026-01-15
50192253067994DoverCardinal Health 200, LLCFCM2026-01-15
50192253068007DoverCardinal Health 200, LLCFCM2026-01-15
50192253070857DoverCardinal Health 200, LLCFCM2026-01-15
50192253027752DoverCardinal Health 200, LLCFCM2025-12-10
50192253028834DoverCardinal Health 200, LLCFCM2025-12-10
50192253028841DoverCardinal Health 200, LLCFCM2025-12-10
50192253030172DoverCardinal Health 200, LLCFCM2025-10-17
40704411019542AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019559AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019566AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019573AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019580AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019597AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019603AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019610AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019627AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019634AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01