Kentex

FDA UDI

Class I (US FDA UDI)

by Kentron Health Care, Inc.

Identity

Trade Name: KENTEX FDA UDI
Generic Name: Emesis bag FDA UDI
Device Name: VOMIT AND URINE BLUE BAG (EMESIS) WITH RIGID PLASTIC COLLAR AND NOTCHES TO SECURE TWISTED BAG FROM LEAKING. FDA UDI
Model / Reference: 404085 FDA UDI
Description: VOMIT AND URINE BLUE BAG (EMESIS) WITH RIGID PLASTIC COLLAR AND NOTCHES TO SECURE TWISTED BAG FROM LEAKING. FDA UDI

Identifiers

Catalog Number: 404085 FDA UDI
Primary DI / UDI-DI: 00810003751249 FDA UDI
FDA Product Code: FNY FDA UDI
GMDN Term: Emesis bag FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6730 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Emesis bag

Kentex by Kentron Health Care, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Centurion — Centurion Medical Products · Class I
Convenience Bag — Typenex Medical, LLC · Class I
ProCure — Twin Med, LLC · Class I
Curaplex — BOUND TREE MEDICAL, LLC · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Kentron Health Care, Inc.

Sources (1)

FDA UDI e24135c3-76cf-41f5-97a9-c3221ea64237 34 fields · synced Jun 1, 2026