FDA.reportPublic FDA data

Dover

Primary DI
20884521176505
Brand
Dover
Company
Cardinal Health, Inc.
Model
PP16XCSD
Catalog number
PP16XCSD
Device description
100% Silicone Silver-Hydrogel Coated Foley Tray with Coude Tip,16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Adhesive Catheter Securement
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
FCNUrinary drainage collection kit, for indwelling catheter
PPGUrinary Drainage Collection Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCNUrinary Drainage Collection Kit, For Indwelling CatheterGastroenterology, Urology2
PPGUrinary Drainage Collection KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521176505PackageGS110In Commercial Distribution
10884521176508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452117650520884521176505
1088452117650810884521176508

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
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
50192253031841DoverCardinal Health 200, LLCPPG2026-03-20
50192253068625DoverCardinal Health 200, LLCPPG2026-01-16
50192253068632DoverCardinal Health 200, LLCPPG2026-01-16
50192253068649DoverCardinal Health 200, LLCPPG2026-01-16
50192253068656DoverCardinal Health 200, LLCPPG2026-01-16
50192253068670DoverCardinal Health 200, LLCPPG2026-01-16
50192253068687DoverCardinal Health 200, LLCPPG2026-01-16
50192253068694DoverCardinal Health 200, LLCPPG2026-01-16
50192253067963DoverCardinal Health 200, LLCPPG2026-01-15
50192253067970DoverCardinal Health 200, LLCPPG2026-01-15
00850063139403Neil Medical Group Neil Medical GroupFCN2025-12-08
00850063139410Neil Medical Group Neil Medical GroupFCN2025-12-08
00850063139427Neil Medical Group Neil Medical GroupFCN2025-12-08
30840330701755ProCureTwin Med, LLCFCN2025-05-31
30840330701762ProCureTwin Med, LLCFCN2025-05-31
30840330701779ProCureTwin Med, LLCFCN2025-05-31
30840330701786ProCureTwin Med, LLCFCN2025-05-31
50192253032015DoverCardinal Health 200, LLCPPG2025-05-29
50192253032060DoverCardinal Health 200, LLCPPG2025-05-29
50192253027967DoverCardinal Health 200, LLCPPG2025-05-14
50192253031285DoverCardinal Health 200, LLCPPG2025-03-20
50192253031582DoverCardinal Health 200, LLCPPG2025-03-20
50192253028094DoverCardinal Health 200, LLCPPG2024-12-20
50192253028100DoverCardinal Health 200, LLCPPG2024-12-20
50192253028063DoverCardinal Health 200, LLCPPG2024-12-20
50192253028117DoverCardinal Health 200, LLCPPG2024-12-20
50192253028124DoverCardinal Health 200, LLCPPG2024-12-20
50192253031247DoverCardinal Health 200, LLCPPG2024-12-20
50192253031537DoverCardinal Health 200, LLCPPG2024-12-20
50192253027684DoverCardinal Health 200, LLCFCN2024-10-14