FDA.reportPublic FDA data

Dover

Primary DI
50192253029015
Brand
Dover
Company
Cardinal Health 200, LLC
Model
145541
Catalog number
145541
Device description
Enema Bag and Tube, Non-Lubricated Tip, 24 Fr/Ch (8.0 mm), 60 in. (1.5 m)
Published
2025-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FCEEnema kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCEEnema KitGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253029015PackageGS150In Commercial Distribution
10192253029017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225302901550192253029015
1019225302901710192253029017

GMDN Terms#

Term, Definition table
TermDefinition
Gravity enema setA collection of devices intended to be used to deliver an injection of fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine. It includes a fluid reservoir (e.g., enema bag) which acts as a gravity-flow chamber, and typically includes enema tube(s) and enema tip; it may be prefilled with a non-medicated enema solution and may be available preassembled. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge24French
Length60Inch
Total Volume1500Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501256ESMARCH'S MEDICAL MUGS SINGLE-USEASSOMEDIKA, OOOFCE2026-05-26
16971919462528Medi GradeNingbo Albert Novosino Co.,Ltd.FCE2025-12-29
10661392011646LSL HEALTHCARELSL Industries, LLCFCE2025-05-16
10661392000909LSL HEALTHCARELSL Industries, LLCFCE2025-05-15
10827989007694Health Care Logistics, Inc®Health Care Logistics, Inc.FCE2025-03-13
10827989007700Health Care Logistics, Inc®Health Care Logistics, Inc.FCE2025-03-13
50192253028995DoverCardinal Health 200, LLCFCE2025-01-16
07333387052564Navina™ Catheter Set ConeWellspect ABFCE2025-01-10
07333387052854Navina Mini Refill SetWellspect ABFCE2024-10-28
07333387052823Navina™ Mini SetWellspect ABFCE2024-10-28
07333387052847Navina Mini Extension SetWellspect ABFCE2024-10-28
07333387052885Navina™ Mini Start SetWellspect ABFCE2024-10-28
06971919461395PREMIUMNingbo Albert Novosino Co.,Ltd.FCE2024-03-11
06971919461401PREMIUMNingbo Albert Novosino Co.,Ltd.FCE2024-03-11
05055270979322RocketROCKET MEDICAL PLCFCE2023-10-24
07333387029719Navina™ Classic System Cone RefillWellspect ABFCE2023-09-25
07333387026985Navina™ Classic System Small RefillWellspect ABFCE2023-09-21
07333387025087Navina™ Catheter Set SmallWellspect ABFCE2023-09-01
07333387025513Navina™Consumable Set SmallWellspect ABFCE2023-09-01
07333387027371Navina™ Smart System RegularWellspect ABFCE2023-09-01
07333387029023Navina™Consumable Set ConeDentsply Ih ABFCE2023-09-01
07333387030104Navina™ Smart System ConeWellspect ABFCE2023-08-30
07333387027739Navina™ Smart System SmallWellspect ABFCE2023-08-23
07333387028736Navina™ Smart Control Unit Wellspect ABFCE2023-01-19
06971919469056NoneNingbo Albert Novosino Co.,Ltd.FCE2022-11-18
50192253013748DoverCardinal Health 200, LLCFCE2022-11-08
50192253013755DoverCardinal Health 200, LLCFCE2022-11-08
00616784471136Cleansing Enema SetDYNAREX CORPORATIONFCE2021-06-21
07392532243905Navina™Consumable Set ConeWellspect ABFCE2019-12-19
07392532243929Navina™ Smart System RegularWellspect ABFCE2019-12-19