FDA.reportPublic FDA data

COMPAT®

Primary DI
20043900950710
Brand
COMPAT®
Company
NESTLE HEALTHCARE NUTRITION, INC.
Model
N/A
Catalog number
08742000
Device description
COMPAT® 20FR 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
OTC
false
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
20043900950710PackageGS15Not in Commercial Distribution
10043900950706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2004390095071020043900950710
1004390095070610043900950706

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 Gauge20French

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
829712640
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
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
10043900950768COMPAT®N/A087424002015-10-16
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
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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10192253006858Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006865Salem SumpCardinal Health 200, LLCKNT2026-01-16
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10192253011326KangarooCardinal Health 200, LLCKNT2024-06-13