FDA.reportPublic FDA data

Dover

Primary DI
50192253013755
Brand
Dover
Company
Cardinal Health 200, LLC
Model
155731
Catalog number
155731
Device description
RECTAL TUBE, PRE-LUBRICATED TIP, 24 FR (8.0 MM) X 20" (51 CM)
Published
2022-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
50192253013755PackageGS150In Commercial Distribution
10192253013757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225301375550192253013755
1019225301375710192253013757

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.

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
false
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
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

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
00661392042483LSL HEALTHCARELSL Industries, LLCFCE2025-10-30
00661392011649LSL HEALTHCARELSL Industries, LLCFCE2025-05-16
10661392011646LSL HEALTHCARELSL Industries, LLCFCE2025-05-16
00661392000902LSL HEALTHCARELSL Industries, LLCFCE2025-05-15
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
10192253028997DoverCardinal Health 200, LLCFCE2025-01-16
10192253029017DoverCardinal Health 200, LLCFCE2025-01-16
50192253028995DoverCardinal Health 200, LLCFCE2025-01-16
50192253029015DoverCardinal Health 200, LLCFCE2025-01-16
07333387024769Navina™ Catheter Set ConeWellspect ABFCE2025-01-10
07333387052601Navina™ Classic System RefillWellspect ABFCE2025-01-10
07333387052625Navina™ Smart SystemWellspect ABFCE2025-01-10
07333387052564Navina™ Catheter Set ConeWellspect ABFCE2025-01-10
07333387052779Navina Mini Refill SetWellspect ABFCE2024-10-28
07333387052816Navina™ Mini SetWellspect ABFCE2024-10-28
07333387052830Navina Mini Extension SetWellspect ABFCE2024-10-28
07333387052878Navina™ Mini Start SetWellspect ABFCE2024-10-28
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
05055270979308RocketROCKET MEDICAL PLCFCE2023-10-24
05055270979322RocketROCKET MEDICAL PLCFCE2023-10-24
07333387029313Navina™ Classic System ConeWellspect ABFCE2023-09-25