LifeBubble

FDA UDI

Class I (US FDA UDI)

by Novonate Inc

Identity

Trade Name: LifeBubble FDA UDI
Generic Name: Wearable percutaneous catheter/tube holder FDA UDI
Device Name: LifeBubble Kit, Large (20/case) FDA UDI
Model / Reference: LKL FDA UDI
Description: LifeBubble Kit, Large (20/case) FDA UDI

Identifiers

Catalog Number: LKL FDA UDI
Primary DI / UDI-DI: 10850002447184 FDA UDI
FDA Product Code: KMK FDA UDI
GMDN Term: Wearable percutaneous catheter/tube holder FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.5210 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Wearable percutaneous catheter/tube holder

LifeBubble by Novonate Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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CathGrip — ARGENTUM MEDICAL, LLC · Class I
Cook — COOK INCORPORATED · Class I
Grip-Lok — TIDI PRODUCTS, 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: Novonate Inc

Sources (1)

FDA UDI 40ddcc67-9f17-41c7-a953-335daea85ae4 34 fields · synced May 30, 2026