FDA.report

Dover

Primary DI
50192253028995
Brand
Dover
Company
Cardinal Health 200, LLC
Model
145524
Catalog number
145524
Device description
Flatus Bag with Rectal Tube, Non-Lubricated Tip 24 Fr/Ch (8.0 mm) x 19 in. (48.3 cm).
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

Related Records

Product Codes

CodeName
FCEEnema kit

Product Code Classifications

CodeDeviceSpecialtyClass
FCEEnema KitGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253028995PackageGS150In Commercial Distribution
10192253028997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225302899550192253028995
1019225302899710192253028997

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.

Device Sizes

TypeValueUnit
Catheter Gauge24French
Length19Inch

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods

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

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