FDA.reportPublic FDA data

Medi Grade

Primary DI
16971919462528
Brand
Medi Grade
Company
Ningbo Albert Novosino Co.,Ltd.
Model
2L
Published
2025-12-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
16971919462528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1697191946252816971919462528

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543014978
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16971919462535Medi Grade60ml2025-12-29
16971919460500Medi Grade20ML2025-11-20
16971919460449Medi Grade500ml2025-11-17
16971919460494Medi Grade90ml2025-11-17
16971919460432Medi Grade75ml2025-11-11
06971919466949noneER813B2023-10-26
06971919462156noneIBS0012025-03-14
06971919460602BieglerJR60010002024-05-24
06971919460619BieglerJR60030002024-05-24
06971919460626BieglerJR50502012024-05-24
06971919460633BieglerJR60602012024-05-24
06971919460657BieglerJR50503012024-05-24
06971919460664BieglerJR60603012024-05-24
06971919461395PREMIUM2L2024-03-11
06971919461401PREMIUM2L2024-03-11
06971919460725ClarifloRU1000PGS2023-04-20
06971919460732ClarifloRU3000PGS2023-04-20
09369998205660Migraine stopper1.02023-05-31
06971919466253Migraine StopperA/02022-08-09
06971919460336BieglerJR50005002023-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501256ESMARCH'S MEDICAL MUGS SINGLE-USEASSOMEDIKA, OOOFCE2026-05-26
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
07333387029702Navina™ Classic System Cone RefillWellspect ABFCE2023-09-25