Clinical Guard

GUDID 24719872486026

Nebulizer

HEALTH & LIFE CO., LTD.

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• Primary Device ID: 24719872486026
• NIH Device Record Key: 6095a3d6-2c28-423c-9c11-10d5bb9c9157
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clinical Guard
• Version Model Number: HL100
• Company DUNS: 657836743
• Company Name: HEALTH & LIFE CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872486022 [Primary]
GS1	14719872486029 [Package]; Contains: 04719872486022; Package: [20 Units]; In Commercial Distribution
GS1	24719872486026 [Package]; Contains: 04719872486022; Package: [150 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081738

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-03

Devices Manufactured by HEALTH & LIFE CO., LTD.

• 14719872486043 - ALERTCARE: 2023-08-14 Nebulizer
• 04719872483380 - PRESTIGE: 2023-06-13 Arm type blood pressure monitor
• 14719872489198 - Homedics: 2023-02-23 Blood pressure cuff of the blood pressure monitor
• 14719872489181 - N/A: 2021-12-22 Blood pressure cuff of the blood monitor
• 14719872483295 - Sunbean: 2021-10-19 Upper Arm Blood Pressure Monitor
• 14719872489167 - Homedics: 2021-10-14 Blood pressure cuff of the blood pressure monitor
• 14719872489174 - N/A: 2021-10-14 Blood pressure cuff of the blood pressure monitor
• 14719872483271 - HM01: 2021-08-10 Arm type blood pressure monitor