SENSIMEDICAL Sterile Water for Inhalation, USP 7871800002

GUDID 00810083350295

Sterile Water for Inhalation, USP, 2000 mL

Sensimedical LLC

Non-heated respiratory humidifier Non-heated respiratory humidifier Non-heated respiratory humidifier Non-heated respiratory humidifier Non-heated respiratory humidifier Non-heated respiratory humidifier Non-heated respiratory humidifier Non-heated respiratory humidifier

• Primary Device ID: 00810083350295
• NIH Device Record Key: a8d7ab9a-0a1d-4470-b064-817d303f856d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SENSIMEDICAL Sterile Water for Inhalation, USP
• Version Model Number: 7871800002
• Catalog Number: 7871800002
• Company DUNS: 117526048
• Company Name: Sensimedical LLC
• 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810083350288 [Package]; Package: [6 Units]; In Commercial Distribution
GS1	00810083350295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K881184

FDA Product Code

• BTT: Humidifier, Respiratory Gas, (Direct Patient Interface)

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: 2022-07-01
• Device Publish Date: 2022-06-23

On-Brand Devices [SENSIMEDICAL Sterile Water for Inhalation, USP]

• 00810083350295: Sterile Water for Inhalation, USP, 2000 mL
• 00810083350264: Sterile Water for Inhalation, USP, 1000 mL