FDA.report

Dover

Primary DI
20884521029610
Brand
Dover
Company
Cardinal Health, Inc.
Model
P4P16XSD
Catalog number
P4P16XSD
Device description
100% Silicone Silver-Hydrogel Coated Urine Meter Foley Tray,16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling and 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

Related Records

Contact Domains

Product Codes

CodeName
FFGDEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
PPGUrinary Drainage Collection Kit

Product Code Classifications

CodeDeviceSpecialtyClass
FFGDevice, Urine Flow Rate Measuring, Non-Electrical, DisposableGastroenterology, Urology2
PPGUrinary Drainage Collection KitGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20884521029610PackageGS110In Commercial Distribution
10884521029613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088452102961020884521029610
1088452102961310884521029613

GMDN Terms

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

TypeValueUnit
Catheter Gauge16French
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

Sterilization Methods

Method

Contacts

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 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 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
20197344156266MEDLINEMEDLINE INDUSTRIES, INC.FFG2025-08-05
20197344157881MEDLINEMEDLINE INDUSTRIES, INC.FFG2025-08-05
50192253032015DoverCardinal Health 200, LLCPPG2025-05-29
50192253032060DoverCardinal Health 200, LLCPPG2025-05-29
50192253027967DoverCardinal Health 200, LLCPPG2025-05-14
50192253028421DoverCardinal Health 200, LLCFFG2025-04-01
50192253031285DoverCardinal Health 200, LLCPPG2025-03-20
50192253031582DoverCardinal Health 200, LLCPPG2025-03-20
50192253028988DoverCardinal Health 200, LLCFFG2025-01-15
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
50192253031742DoverCardinal Health 200, LLCPPG2024-08-22
50192253031759DoverCardinal Health 200, LLCPPG2024-08-22
50192253031766DoverCardinal Health 200, LLCPPG2024-08-22
50192253031773DoverCardinal Health 200, LLCPPG2024-08-22