FDA.reportPublic FDA data

Cleansing Enema Set

Primary DI
00616784471129
Brand
Cleansing Enema Set
Company
Dynarex Corporation
Model
4711
Device description
"Cleansing Enema Set: 1500mL Enema Bag, 60"" Inlet Tubing, Tubing Clamp, Protection Clamp, Protection Cap, Castile Soap Concentrate, 45x42cm Moisture Proof Drape"
Published
2021-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00616784471136PackageGS150In Commercial Distribution
00616784471129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784471136006167844711366167844711360616784471136
00616784471129006167844711296167844711290616784471129

GMDN Terms#

Term, Definition table
TermDefinition
Manual enema device, single-useA device intended to be used to manually administer fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine through expansion of the lower intestinal tract and physical stimulation of peristalsis. The device consists of a hand-held fluid reservoir (e.g., bottle, bulb) with a nozzle from which an enema solution is intended to be administered by squeezing the filled reservoir following insertion of the nozzle into the rectum; it may be prefilled with a non-medicated enema solution. It is intended for use in the home or healthcare facility. This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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