NURSE ASSIST, INC.

GUDID B15027600

NURSE ASSIST, INC.

Tracheostomy care kit

• Primary Device ID: B15027600
• NIH Device Record Key: 95c31f15-62ce-4708-b631-956ba972e87c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NURSE ASSIST, INC.
• Version Model Number: 2760
• 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	B15027600 [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: 2017-06-01

Devices Manufactured by NURSE ASSIST, INC.

• 00850421008976 - Stericare: 2026-03-20 USP Sterile Water, 500 mL Bottle, Each, Square Tamper Evid HWC Ster
• 00850421008983 - Stericare: 2026-03-20 USP Normal Saline (0.9% Sodium Chloride), 500 mL Bottle, Each, Square Tamper Evid HWC Ster
• 00850421008990 - Stericare: 2026-03-20 USP Normal Saline (0.9% Sodium Chloride), 1000 mL Bottle, Square Tamper Evid HWC Ster
• 00860013668501 - Stericare: 2026-03-20 USP Sterile Water, 1000 mL Bottle, Each, Square Tamper Evid HWC Ster
• 03085042100878 - Stericare: 2026-03-20 USP Sterile Water, 500 mL Bottle, Case of 18 units, Square Tamper Evid HWC Ster
• 10860013668508 - Stericare: 2026-03-20 USP Normal Saline (0.9% Sodium Chloride), 1000 mL Bottle, Case of 9 units, Square Tamper Evid HWC Ster
• 10850421008928 - NURSE ASSIST: 2024-07-18 0.9% Sodium Chloride IV Flush Syringe for Sterile Delivery, 10mL Fill, 1210-SF, Syringe/Pouch
• 00850421008198 - SteriCare Solutions: 2024-02-16 USP Normal Saline, 500 mL Bottle