FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50192253011553
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
8884720221E
Catalog number
8884720221E
Device description
Gastrostomy Feeding Tube With ENFit Y-Port 22 Fr/Ch (7.3 mm) with 20 mL Balloon
Published
2025-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PIFGastrointestinal Tubes with Enteral Specific Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIFGastrointestinal Tubes With Enteral Specific ConnectorsGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253011553PackageGS15In Commercial Distribution
10192253011555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225301155350192253011553
1019225301155510192253011555

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge22French
Total Volume20Milliliter

Sterilization Methods#

Method table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253012460Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253012484Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253012507Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253012521Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253012989Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253013009Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253060928Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253068764CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068771CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068788CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068795CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068801CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068818CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068825CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068832CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253011449CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011463CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011487CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011517CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011531CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011555CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011579CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011593CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011616CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10850016172485KBMEDKB Medical (group), Inc.PIF2025-05-21
10850016172492KBMEDKB Medical (group), Inc.PIF2025-05-21
10192253007572ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007596ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007619ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007633ArgyleCardinal Health 200, LLCPIF2025-04-24