ESMARCH'S MEDICAL MUGS SINGLE-USE

Primary DI
04816415501256
Brand
ESMARCH'S MEDICAL MUGS SINGLE-USE
Company
ASSOMEDIKA, OOO
Model
N/A
Device description
A 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.
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FCEEnema Kit

Product Code Classifications

CodeDeviceSpecialtyClass
FCEEnema KitGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04816415501256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04816415501256048164155012564816415501256

GMDN Terms

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.

Regulatory Flags

DUNS number
683522555
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04816415501263FOOT URINE COLLECTORN/A2026-05-26
04816415501270BEDSIDE URINE COLLECTORN/A2026-05-26
04816415501287BREATHING MASK Single Use Size 0N/A2026-05-26
04816415501294BREATHING MASK Single Use Size 3N/A2026-05-26
04816415501300BREATHING MASK Single Use Size 6N/A2026-05-26
04816415501317BREATHING MASK Reusable Size 0N/A2026-05-26
04816415501324BREATHING MASK Reusable Size 3N/A2026-05-26
04816415501331BREATHING MASK Reusable Size 5N/A2026-05-26
04816415501348OXYGEN MASK Single Use Size 4 with nebulizerN/A2026-05-26
04816415501355OXYGEN MASK Single Use Size 4 with bagN/A2026-05-26
04816415501362OXYGEN MASK Single Use Size 4N/A2026-05-26

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