MEDICAL ACTION

GUDID B15041280

NURSE ASSIST, INC.

Tracheostomy care kit

• Primary Device ID: B15041280
• NIH Device Record Key: 265ef807-138f-44b1-98ac-dbe3a8bd26db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDICAL ACTION
• Version Model Number: 4128
• Company DUNS: 869434464
• Company Name: NURSE ASSIST, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B15041280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K842166

FDA Product Code

• BSY: Catheters, Suction, Tracheobronchial

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-01

On-Brand Devices [MEDICAL ACTION]

• B15041290: 4129
• B15041280: 4128
• B15041200: 4120
• B15041180: 4118