FDA.reportPublic FDA data

COMPAT®

Primary DI
10043900950768
Brand
COMPAT®
Company
NESTLE HEALTHCARE NUTRITION, INC.
Model
N/A
Catalog number
08742400
Device description
"COMPAT® 24FR Replacement Balloon Gastrostomy Tube with Universal ""Y"" Adapter and Stretch Lok Strap"
Published
2015-10-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K885339000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K885339000FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KITSuperior Healthcare Group, Inc.1989-03-01KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20043900950772PackageGS15Not in Commercial Distribution
10043900950768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2004390095077220043900950772
1004390095076810043900950768

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 Gauge24French

Contacts#

Phone, Email table
PhoneEmail
1-877-338-4238xxx@xx.xx

Regulatory Flags#

DUNS number
829712640
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10043900950614COMPAT®N/A087414002015-10-16
10043900950645COMPAT®N/A087416002015-10-16
10043900950676COMPAT®N/A087418002015-10-16
10043900950706COMPAT®N/A087420002015-10-16
10043900950737COMPAT®N/A087422002015-10-16
10043900950461COMPAT®N/A122628292016-02-22
10043900950492COMPAT®N/A122628302016-02-22
10043900950522COMPAT®N/A122628312016-02-22
20043900950628COMPAT®N/A087414002015-10-16
20043900950659COMPAT®N/A087416002015-10-16
20043900950680COMPAT®N/A087418002015-10-16
20043900950710COMPAT®N/A087420002015-10-16
20043900950741COMPAT®N/A087422002015-10-16
20043900950772COMPAT®N/A087424002015-10-16
10043900950348COMPAT®N/A122628252016-02-22
10043900950553COMPAT®N/A122628322016-02-22
10043900950584COMPAT®N/A122628332016-02-22

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Primary DI, Brand, Company table
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00816340021656EL-S55-HFNEODEVICES INCKNT2026-06-01
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10192253006834Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006841Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006858Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006865Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253011449CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011463CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011487CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011517CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011531CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011555CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011579CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011593CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
08015262035662NUTRIFITPENTAFERTE ITALIA SRLKNT2025-07-03
10192253011128KangarooCardinal Health 200, LLCKNT2025-05-28
10192253011159CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011173CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011197CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011227CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011258CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011272CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011296CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011104KangarooCardinal Health 200, LLCKNT2025-01-14
G461EGCT36M0EndolumikEndolumik, Inc.KNT2024-08-06
G461EGCT40M0EndolumikEndolumik, Inc.KNT2024-08-06
10192253011319KangarooCardinal Health 200, LLCKNT2024-06-13
10192253011326KangarooCardinal Health 200, LLCKNT2024-06-13