FDA.reportPublic FDA data

Gabriel Feeding Tube with Balloon

Primary DI
00860000931335
Brand
Gabriel Feeding Tube with Balloon
Company
SYNCRO MEDICAL INNOVATIONS
Model
8 Fr
Catalog number
GFTB 508
Device description
and EnFit Connector
Published
2020-02-18
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191784000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191784000Gabriel Feeding Tube with Balloon, and EnFit ConnectorSyncro Medical Innovations, Inc.2019-11-15PIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860000931332PackageGS110In Commercial Distribution
00860000931335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000093133210860000931332
00860000931335008600009313358600009313350860000931335

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 Gauge8French
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(888)980-9159sabrygabriel@syncomedical.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
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
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
10192253007572ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007596ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007619ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007633ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007657ArgyleCardinal Health 200, LLCPIF2025-04-24
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10192253007817KangarooCardinal Health 200, LLCPIF2025-04-24
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08015262022259VYGONVygon CorporationKNT2024-05-08
10192253007565ArgyleCardinal Health 200, LLCKNT2024-04-12
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10192253007626ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007640ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007763ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007800KangarooCardinal Health 200, LLCKNT2024-04-12
10192253006582KangarooCardinal Health 200, LLCKNT2024-03-25
10192253006599KangarooCardinal Health 200, LLCKNT2024-03-25
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10192253007145KangarooCardinal Health 200, LLCKNT2024-03-25
08015262022242VYGONVygon CorporationKNT2024-03-14