FDA.reportPublic FDA data

VESCO

Primary DI
20813939024962
Brand
VESCO
Company
XERIDIEM MEDICAL DEVICES, INC.
Model
70-0062-224
Device description
24 Fr - Gastrostomy Tube - Dual ENFit Port (Tri-Funnel)
Published
2025-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
20813939024962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081393902496220813939024962

GMDN Terms#

Term, Definition table
TermDefinition
Enteral feeding noninvasive-component setA collection of devices such as tubing, connectors, chambers, clamps, and bags/bottles intended to be used to create the noninvasive (i.e., fully external) portion of an enteral feeding device assembly; it is not intended for intravenous (IV) administration. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
520-975-9508maia.kirk@spectrumplastics.com
4805502292David.Hutchinson@SpectrumPlastics.com

Regulatory Flags#

DUNS number
183325125
Device count
1
Lot or batch
true
Expiration date on label
true

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
00842071136642MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136659MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136666MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136673MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136680MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136697MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136703MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136710MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136727MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136734MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136741MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136758MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136765MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136772MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136789MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136796MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136802MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136819MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136826MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136833MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136840MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136857MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136864MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136871MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136888MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136895MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136901MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136918MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136925MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136932MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30