FDA.reportPublic FDA data

Entuit Thrive LP

Primary DI
00827002356887
Brand
Entuit Thrive LP
Company
XERIDIEM MEDICAL DEVICES, INC.
Model
EntuitTM Thrive LP Balloon Retention Gastrostomy F
Catalog number
70-0042-922
Published
2015-06-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130674000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130674000ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBEXeridiem Medical Devices2014-01-13KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002356887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002356887008270023568878270023568870827002356887

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

Regulatory Flags#

DUNS number
183325125
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
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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