Entuit Thrive LP 70-0042-616

GUDID 00827002356573

XERIDIEM MEDICAL DEVICES, INC.

Gastrostomy tube
Primary Device ID00827002356573
NIH Device Record Key081b171c-e176-4e28-aa48-adb1154b20ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameEntuit Thrive LP
Version Model NumberEntuitTM Thrive LP Balloon Retention Gastrostomy F
Catalog Number70-0042-616
Company DUNS183325125
Company NameXERIDIEM MEDICAL DEVICES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100827002356573 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNTTubes, Gastrointestinal (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-07
Device Publish Date2015-06-22

On-Brand Devices [Entuit Thrive LP]

00827002356986EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356979EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356962EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356955EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356948EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356931EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356924EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356917EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356900EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356894EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356887EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356870EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356863EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356856EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356849EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356825EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356818EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356801EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356795EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356788EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356771EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356764EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356757EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356740EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356733EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356726EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356719EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356702EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356696EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356689EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356672EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356665EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356658EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356641EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356634EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356627EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356610EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356603EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356597EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356580EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356573EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356566EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356559EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356542EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356535EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356528EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356511EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356504EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356498EntuitTM Thrive LP Balloon Retention Gastrostomy F
00827002356481EntuitTM Thrive LP Balloon Retention Gastrostomy F

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.