LifeBubble LBS

GUDID 00850002447200

LifeBubble, Small (20/case)

NOVONATE INC

Wearable percutaneous catheter/tube holder

• Primary Device ID: 00850002447200
• NIH Device Record Key: c2160834-1830-4ef5-b1e9-22f6e798fdc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifeBubble
• Version Model Number: LBS
• Catalog Number: LBS
• Company DUNS: 080564237
• Company Name: NOVONATE INC
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850002447101 [Previous]
GS1	00850002447200 [Unit of Use]
GS1	10850002447207 [Primary]

FDA Product Code

• KMK: Device, Intravascular Catheter Securement

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-14
• Device Publish Date: 2022-02-04

On-Brand Devices [LifeBubble]

• 00850002447934: Adhesive Pack (20/case)
• 00850002447927: LifeBubble Kit, Umbilical Catheter Securement System (20/Case)
• 00850002447910: Umbilical Catheter Securement System (20/case)
• 00850002447149: Adhesive Pack, Small (20/Case)
• 00850002447132: LifeBubble, Small (20/Case)
• 00850002447125: LifeBubble Kit, Small (20/Case)
• 00850002447262: LifeBubble Buddy (40/case)
• 00850002447248: LifeBubble Kit, Small (20/case)
• 00850002447224: Adhesive Pack, Small (20/case)
• 00850002447200: LifeBubble, Small (20/case)
• 00850002447187: LifeBubble Kit, Large (20/case)
• 00850002447163: Adhesive Pack, Large (20/case)
• 00850002447088: LifeBubble, Large (20/case)
• 00850002447316: LifeBubble Evaluation Kit (30/case)
• 00850002447972: LifeBubble Buddy, Catheter Insertion Site Access Tool (40/Case)