FDA.report

CARDINAL HEALTH

Primary DI
50192253068779
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
8884715148E
Catalog number
8884715148E
Device description
Gastrostomy Feeding Tube With ENFit Y-Port 14 Fr/Ch (4.7 mm) with 5 mL Balloon
Published
2026-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KNTTubes, gastrointestinal (and accessories)

Product Code Classifications

CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253068779PackageGS15In Commercial Distribution
10192253068771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225306877950192253068779
1019225306877110192253068771

GMDN Terms

TermDefinition
Gastrostomy tubeA thin, flexible, percutaneous, hollow tube which may include additional external components (e.g., external tubing, syringe) intended to be percutaneously inserted into the stomach to feed a patient with a physical disability that prevents oral feeding (e.g., a birth defect of the stomach), and/or provide drainage/decompression of the stomach when it is necessary to bypass an obstruction of the stomach outlet into the small intestine. Although noninvasive disposable enteral feeding components may be included, surgical instruments and pharmaceutical agents are not included. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge14French
Total Volume5Milliliter

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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