FDA.reportPublic FDA data

Silicone Gastrostomy Tube with ENFit Connector (Bi-Funnel)

Primary DI
00813939024883
Brand
Silicone Gastrostomy Tube with ENFit Connector (Bi-Funnel)
Company
XERIDIEM MEDICAL DEVICES, INC.
Model
70-0056-220
Catalog number
70-0056-220
Device description
Silicone Gastrostomy Tube with ENFit Connector (Bi-Funnel) 20FR
Published
2016-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PIFGastrointestinal Tubes With Enteral Specific Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIFGastrointestinal Tubes With Enteral Specific ConnectorsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142075000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142075000BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBEXeridiem (Formerly Mri)2015-01-08PIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813939024883PackageGS15In Commercial Distribution
00813939024746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813939024883008139390248838139390248830813939024883
00813939024746008139390247468139390247460813939024746

GMDN Terms#

Term, Definition table
TermDefinition
Gastrostomy tubeA thin, flexible, hollow tube intended to be percutaneously inserted into the stomach, typically through puncture of the abdominal wall and stomach after distention of the stomach by endoscopic methods. It is intended 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. Additional disposable enteral feeding components (e.g., external tubing, syringe) may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(520) 882-7794smurray@xeridiem.com

Regulatory Flags#

DUNS number
183325125
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002447806Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit ConnectionSBRD-12-ENF70-0060-1122016-08-01
00827002447813Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit ConnectionSBRD-14-ENF70-0060-1142016-08-01
00827002447837Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit ConnectionSBRD-18-ENF70-0060-1182016-08-01
00827002447844Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit ConnectionSBRD-20-ENF70-0060-2202016-08-01
00827002447851Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit ConnectionSBRD-22-ENF70-0060-2222016-08-01
00827002447868Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit ConnectionSBRD-24-ENF70-0060-2242016-08-01
00827002356214Entuit Thrive LPEntuitTM Thrive LP Balloon Retention Gastrostomy F70-0042-0122015-06-22
00827002356221Entuit Thrive LPEntuitTM Thrive LP Balloon Retention Gastrostomy F70-0042-1122015-06-22
00827002356368Entuit Thrive LPEntuitTM Thrive LP Balloon Retention Gastrostomy F70-0042-3122015-06-22
00827002356375Entuit Thrive LPEntuitTM Thrive LP Balloon Retention Gastrostomy F70-0042-4122015-06-22
00827002356382Entuit Thrive LPEntuitTM Thrive LP Balloon Retention Gastrostomy F70-0042-5122015-06-22
00827002356399Entuit Thrive LPEntuitTM Thrive LP Balloon Retention Gastrostomy F70-0042-6122015-06-22
00827002356405Entuit Thrive LPEntuitTM Thrive LP Balloon Retention Gastrostomy F70-0042-7122015-06-22
00827002356412Entuit Thrive LPEntuitTM Thrive LP Balloon Retention Gastrostomy F70-0042-0142015-06-22
00827002356429Entuit Thrive LPEntuitTM Thrive LP Balloon Retention Gastrostomy F70-0042-1142015-06-22
00827002356436Entuit Thrive LPEntuitTM Thrive LP Balloon Retention Gastrostomy F70-0042-2142015-06-22
00827002356443Entuit Thrive LPEntuitTM Thrive LP Balloon Retention Gastrostomy F70-0042-3142015-06-22
00827002356450Entuit Thrive LPEntuitTM Thrive LP Balloon Retention Gastrostomy F70-0042-4142015-06-22
00827002356467Entuit Thrive LPEntuitTM Thrive LP Balloon Retention Gastrostomy F70-0042-5142015-06-22
00827002356474Entuit Thrive LPEntuitTM Thrive LP Balloon Retention Gastrostomy F70-0042-6142015-06-22

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