FDA.reportPublic FDA data

Gabriel Feeding Tube with Balloon

Primary DI
00860000931359
Brand
Gabriel Feeding Tube with Balloon
Company
SYNCRO MEDICAL INNOVATIONS
Model
12 Fr
Catalog number
GFTB 512
Device description
and EnFit Connector
Published
2020-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)
PIFGastrointestinal Tubes With Enteral Specific Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2
PIFGastrointestinal Tubes With Enteral Specific ConnectorsGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860000931356PackageGS110In Commercial Distribution
00860000931359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000093135610860000931356
00860000931359008600009313598600009313590860000931359

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
Catheter Gauge12French
Device Size Text, specify0

Contacts#

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

Regulatory Flags#

DUNS number
001058887
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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
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
10860000931325Gabriel Feeding Tube with Balloon12 FrGFTB 4122019-01-24

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Primary DI, Brand, Company table
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08015262035662NUTRIFITPENTAFERTE ITALIA SRLKNT2025-07-03
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10192253007763ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007800KangarooCardinal Health 200, LLCKNT2024-04-12
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