FDA.reportPublic FDA data

Biotronix Healthcare

Primary DI
00850005165286
Brand
Biotronix Healthcare
Company
BIOTRONIX HEALTHCARE INDUSTRIES, INC.
Model
GEED53007
Catalog number
GEED53007
Device description
Enteral Delivery Gravity Bag Set w/ ENFit™* Connector
Published
2019-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K181276000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181276000CONOD Enteral Feeding SetsConod Medical Co., Limited2018-07-12PIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850005165283PackageGS130In Commercial Distribution
00850005165286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000516528310850005165283
00850005165286008500051652868500051652860850005165286

GMDN Terms#

Term, Definition table
TermDefinition
Enteral feeding kit, adult/paediatric, non-sterileA collection of non-sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an adult or paediatric (excludes infants) patient by means of gravity or an enteral pump. This is a single-use device.

Device Sizes#

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

Contacts#

Phone, Email table
PhoneEmail
786-473-9436mborges@biotronixhealthcare.com

Regulatory Flags#

DUNS number
065762392
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
00850005165576Biotroix Healthcare SyringesGE12010SGE12010S2024-03-11
00850005165798Biotronix Healthcare SyringesGE12035GE120352019-10-18
00858835007202Biotronix HealthCare SyringesGE12012GE120122019-10-10
00858835007219Biotronix HealthCare SyringesGE12010GE120102019-10-10
00858835007226Biotronix Healthcare SyringesGE12033GE120332019-10-10
00858835007233Biotronix Healthcare SyringesGE12034GE120342019-10-12
00858835007240Biotronix Healthcare SyringesGE12030GE120302019-10-12
00858835007257Biotronix Healthcare SyringesGE12032GE120322019-10-12
00858835007264Biotronix Healthcare SyringesGE12029GE120292019-10-12
00858835007271Biotronix Healthcare SyringesGE12047GE120472019-10-12
00858835007288Biotronix Healthcare SyringesGE12055GE120552019-10-12
00858835007295Biotronix Healthcare SyringesGE12053GE120532019-10-12
00858835007318Biotronix Healthcare SyringesGE12023GE120232019-10-12
00858835007332Biotronix Healthcare SyringesGE12025GE120252019-10-12
00858835007349Biotronix Healthcare SyringesE12026GE120262019-10-12
00858835007356Biotronix Healthcare SyringesGE12027GE120272019-10-12
00858835007783Biotronix Healthcare SyringesGE12026GE120262019-10-12
00864085000405Biotronix Healthcare SyringesGE12085GE120852019-10-13
00864085000412Biotronix Healthcare SyringesGE12041GE120412019-10-13
00858835007004Biotronix HealthcareGE36419GE364192019-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071153083NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153106NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153120NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00816340021632EL-SPIKE-MNEODEVICES INCKNT2026-06-01
00816340021649EL-SPIKE-FNEODEVICES INCKNT2026-06-01
00816340021656EL-S55-HFNEODEVICES INCKNT2026-06-01
05060999351564EnteralGBUK GROUP LIMITEDPIF2025-08-20
05060999351595EnteralGBUK GROUP LIMITEDPIF2025-08-20
05060999351625EnteralGBUK GROUP LIMITEDPIF2025-08-20
05060999351656EnteralGBUK GROUP LIMITEDPIF2025-08-20
08015262035662NUTRIFITPENTAFERTE ITALIA SRLKNT2025-07-03
05060999350017NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350048NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350079NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350109NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350130NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350161NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350192NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350222NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350253NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350284NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350314NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350345NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350376NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350451NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350482NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350512NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350543NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350574NutricareGBUK GROUP LIMITEDPIF2024-10-29
05060999350604NutricareGBUK GROUP LIMITEDPIF2024-10-29