FDA.reportPublic FDA data

Gabriel Feeding Tube with Balloon

Primary DI
10860000931325
Brand
Gabriel Feeding Tube with Balloon
Company
SYNCRO MEDICAL INNOVATIONS
Model
12 Fr
Catalog number
GFTB 412
Device description
Preassembeled with Stylet
Published
2019-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
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
K160787000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160787000Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with StyletSyncro Medical Innovations, Inc.2016-08-09KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860000931325PackageGS110In Commercial Distribution
00860000931328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000093132510860000931325
00860000931328008600009313288600009313280860000931328

GMDN Terms#

Term, Definition table
TermDefinition
Nasogastric feeding tubeA sterile, thin, flexible, hollow cylinder intended to access the stomach of a patient through the nose and nasopharynx primarily for enteral feeding and the administration of medications, either by gravity or with a pump; it may also be used for aspiration of gastric contents (e.g., gastric secretions). It is typically a single lumen, rubber or plastic tube of various diameters (typically smaller than those of nasogastric tubes intended primarily for decompression) with circular markings that serve as insertion guides. It is frequently used for very ill or comatose patients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)980-9159sabrygabriel@syncromedical.com

Regulatory Flags#

DUNS number
001058887
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860000931366Gabriel 3-way EnFit ValveGEV-0001GEV-00012021-02-07
00860000931335Gabriel Feeding Tube with Balloon8 FrGFTB 5082020-02-18
00860000931342Gabriel Feeding Tube with Balloon10 FrGFTB 5102020-02-18
10860000931332Gabriel Feeding Tube with Balloon8 FrGFTB 5082020-02-18
10860000931349Gabriel Feeding Tube with Balloon10 FrGFTB 5102020-02-18
00860000931359Gabriel Feeding Tube with Balloon12 FrGFTB 5122020-02-13
10860000931356Gabriel Feeding Tube with Balloon12 FrGFTB 5122020-02-13
00860000931304Gabriel Feeding Tube with Balloon8 FrGFTB 4082019-01-24
00860000931311Gabriel Feeding Tube with Balloon10 FrGFTB 4102019-01-24
00860000931328Gabriel Feeding Tube with Balloon12 FrGFTB 4122019-01-24
10860000931301Gabriel Feeding Tube with Balloon8 FrGFTB 4082019-01-24
10860000931318Gabriel Feeding Tube with Balloon10 FrGFTB 4102019-01-24

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10192253006865Salem SumpCardinal Health 200, LLCKNT2026-01-16
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08015262035662NUTRIFITPENTAFERTE ITALIA SRLKNT2025-07-03
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