Entuit Thrive LP

FDA UDI

Class II (US FDA UDI)

by Xeridiem Medical Devices

Identity

Trade Name: Entuit Thrive LP FDA UDI
Generic Name: Gastrostomy tube FDA UDI
Model / Reference: EntuitTM Thrive LP Balloon Retention Gastrostomy Feeding Tube - 16 FR/4.5cm FDA UDI

Identifiers

Catalog Number: 70-0042-816 FDA UDI
Primary DI / UDI-DI: 00827002356597 FDA UDI
510(k) Number: K130674 FDA UDI
FDA Product Code: KNT FDA UDI
GMDN Term: Gastrostomy tube FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5980 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Gastrostomy tube

Entuit Thrive LP by Xeridiem Medical Devices — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrostomy tube.

Balloon G-Tube — Applied Medical Technology, Inc. · Class II
AMT Balloon G-Tube — Applied Medical Technology, Inc. · Class II
AVANOS — Avanos Medical, Inc. · Class II
Low-Profile Gastrostomy Replacement Tube (G. Button) Kit — Sky Medical a.s. · Class IIb
Kangaroo — Cardinalhealth · Class II
Gastrostomy Tube — Hangzhou Fushan Medical Appliances Co., Ltd. · Class IIa
EndoVive™ Low Profile Replacement Button — Boston Scientific · Class II
AMT Capsule Dome G-Tube — Applied Medical Technology, Inc. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Xeridiem Medical Devices

Sources (1)

FDA UDI 0dcb533b-4c3d-4ba9-98f4-54b42856acb6 34 fields · synced May 30, 2026