LifeBubble LK20

GUDID 00850002447927

LifeBubble Kit, Umbilical Catheter Securement System (20/Case)

NOVONATE INC

Wearable percutaneous catheter/tube holder

• Primary Device ID: 00850002447927
• NIH Device Record Key: ce9490f2-a785-4c52-91e1-ae745d0ac07b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifeBubble
• Version Model Number: LK20
• Catalog Number: LK20
• 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: true
• 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 Dimensions

• Catheter Gauge: 3.5 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850002447927 [Primary]
GS1	00850002447958 [Unit of Use]

FDA Product Code

• KMK: Device, Intravascular Catheter Securement

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-20
• Device Publish Date: 2019-09-12

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)