FDA.reportPublic FDA data

Gastrostomy Feeding Tube with ENFit Connector

Primary DI
00813939025170
Brand
Gastrostomy Feeding Tube with ENFit Connector
Company
XERIDIEM MEDICAL DEVICES, INC.
Model
8884720247X
Catalog number
70-0068-224
Device description
Gastrostomy Feeding Tube with ENFit Connector 24FR
Published
2018-01-16
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
K171347000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171347000Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit ConnectionXeridiem Medical Devices2017-06-06PIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813939025170PackageGS15In Commercial Distribution
00813939025101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813939025170008139390251708139390251700813939025170
00813939025101008139390251018139390251010813939025101

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253012460Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253012484Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253012507Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253012521Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253012989Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253013009Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253060928Salem SumpCardinal Health 200, LLCPIF2026-03-19
10192253068764CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068771CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068788CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068795CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068801CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068818CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068825CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253068832CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
10192253011449CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011463CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011487CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011517CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011531CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011555CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011579CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011593CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10192253011616CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
10850016172485KBMEDKB Medical (group), Inc.PIF2025-05-21
10850016172492KBMEDKB Medical (group), Inc.PIF2025-05-21
10192253007572ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007596ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007619ArgyleCardinal Health 200, LLCPIF2025-04-24
10192253007633ArgyleCardinal Health 200, LLCPIF2025-04-24