LifeBubble LK20-S

GUDID 00850002447125

LifeBubble Kit, Small (20/Case)

NOVONATE INC

Wearable percutaneous catheter/tube holder
Primary Device ID00850002447125
NIH Device Record Key3df996fe-5ae5-4a5c-9cb6-87f8aa3d78f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameLifeBubble
Version Model NumberLK20-S
Catalog NumberLK20-S
Company DUNS080564237
Company NameNOVONATE INC
Device Count20
DM Exemptfalse
Pre-market Exempttrue
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Catheter Gauge5 French
Catheter Gauge3.5 French
Catheter Gauge5 French
Catheter Gauge3.5 French
Catheter Gauge5 French
Catheter Gauge3.5 French
Catheter Gauge5 French
Catheter Gauge3.5 French
Catheter Gauge5 French
Catheter Gauge3.5 French
Catheter Gauge5 French
Catheter Gauge3.5 French
Catheter Gauge5 French
Catheter Gauge3.5 French
Catheter Gauge5 French
Catheter Gauge3.5 French
Catheter Gauge5 French
Catheter Gauge3.5 French
Catheter Gauge5 French
Catheter Gauge3.5 French
Catheter Gauge5 French
Catheter Gauge3.5 French
Catheter Gauge5 French
Catheter Gauge3.5 French
Catheter Gauge5 French
Catheter Gauge3.5 French
Catheter Gauge5 French
Catheter Gauge3.5 French
Catheter Gauge5 French
Catheter Gauge3.5 French
Catheter Gauge5 French
Catheter Gauge3.5 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100850002447095 [Primary]
GS100850002447125 [Unit of Use]

FDA Product Code

KMKDevice, Intravascular Catheter Securement

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-19
Device Publish Date2021-10-11

On-Brand Devices [LifeBubble]

00850002447934Adhesive Pack (20/case)
00850002447927LifeBubble Kit, Umbilical Catheter Securement System (20/Case)
00850002447910Umbilical Catheter Securement System (20/case)
00850002447149Adhesive Pack, Small (20/Case)
00850002447132LifeBubble, Small (20/Case)
00850002447125LifeBubble Kit, Small (20/Case)
00850002447262LifeBubble Buddy (40/case)
00850002447248LifeBubble Kit, Small (20/case)
00850002447224Adhesive Pack, Small (20/case)
00850002447200LifeBubble, Small (20/case)
00850002447187LifeBubble Kit, Large (20/case)
00850002447163Adhesive Pack, Large (20/case)
00850002447088LifeBubble, Large (20/case)

Trademark Results [LifeBubble]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LIFEBUBBLE
LIFEBUBBLE
97862932 not registered Live/Pending
Novonate, Inc.
2023-03-29

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.