FDA.report

Dover

Primary DI
50192253032053
Brand
Dover
Company
Cardinal Health 200, LLC
Model
PP16XSD
Catalog number
PP16XSD
Device description
100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2-WAY, CATH SECUREMENT
Published
2024-08-22
Public version status
New
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

Product Codes

CodeName
PPGUrinary drainage collection kit

Product Code Classifications

CodeDeviceSpecialtyClass
PPGUrinary Drainage Collection KitGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253032053PackageGS110In Commercial Distribution
10192253032055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225303205350192253032053
1019225303205510192253032055

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

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

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
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
50192253031742DoverCardinal Health 200, LLCPPG2024-08-22
50192253031759DoverCardinal Health 200, LLCPPG2024-08-22
50192253031766DoverCardinal Health 200, LLCPPG2024-08-22
50192253031773DoverCardinal Health 200, LLCPPG2024-08-22
50192253031803DoverCardinal Health 200, LLCPPG2024-08-22
50192253031827DoverCardinal Health 200, LLCPPG2024-08-22
50192253031834DoverCardinal Health 200, LLCPPG2024-08-22
50192253031858DoverCardinal Health 200, LLCPPG2024-08-22