FDA.reportPublic FDA data

Dover

Primary DI
10192253028065
Brand
Dover
Company
Cardinal Health 200, LLC
Model
6070
Catalog number
6070
Device description
100% SILICONE FOLEY TRAY, NEEDLE PORT, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT
Published
2024-12-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PPGUrinary drainage collection kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPGUrinary Drainage Collection KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253028063PackageGS110Not in Commercial Distribution
10192253028065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225302806350192253028063
1019225302806510192253028065

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 Gauge14French
Total Volume2000Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253071085DoverCardinal Health 200, LLCPPG2026-06-24
10192253071092DoverCardinal Health 200, LLCPPG2026-06-24
10192253068023DoverCardinal Health 200, LLCPPG2026-06-23
10192253068030DoverCardinal Health 200, LLCPPG2026-06-23
10192253068047DoverCardinal Health 200, LLCPPG2026-06-23
10192253068054DoverCardinal Health 200, LLCPPG2026-06-23
10192253031843DoverCardinal Health 200, LLCPPG2026-03-20
50192253031841DoverCardinal Health 200, LLCPPG2026-03-20
10192253031799DoverCardinal Health 200, LLCPPG2026-02-24
10192253031881DoverCardinal Health 200, LLCPPG2026-02-24
10192253031935DoverCardinal Health 200, LLCPPG2026-02-24
10192253032048DoverCardinal Health 200, LLCPPG2026-02-24
10192253032093DoverCardinal Health 200, LLCPPG2026-02-24
10192253068627DoverCardinal Health 200, LLCPPG2026-01-16
10192253068634DoverCardinal Health 200, LLCPPG2026-01-16
10192253068641DoverCardinal Health 200, LLCPPG2026-01-16
10192253068658DoverCardinal Health 200, LLCPPG2026-01-16
10192253068672DoverCardinal Health 200, LLCPPG2026-01-16
10192253068689DoverCardinal Health 200, LLCPPG2026-01-16
10192253068696DoverCardinal Health 200, LLCPPG2026-01-16
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
10192253067965DoverCardinal Health 200, LLCPPG2026-01-15
10192253067972DoverCardinal Health 200, LLCPPG2026-01-15
50192253067963DoverCardinal Health 200, LLCPPG2026-01-15