NOVAPLUS Sterile Water for Inhalation, USP V7871800002

GUDID 00810083350349

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: 00810083350349
• NIH Device Record Key: fb8d829f-5ab1-4ccd-91e2-7673894cd01a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVAPLUS Sterile Water for Inhalation, USP
• Version Model Number: V7871800002
• Catalog Number: V7871800002
• 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	00810083350349 [Package]; Contains: 00810083350356; Package: [6 Units]; In Commercial Distribution
GS1	00810083350356 [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

Devices Manufactured by Sensimedical LLC

• 00810083350431 - BIOSITE / BIOSITE PLUS: 2024-01-12 JR-009-TU 60 psi Transparent Needleless Neutral Valve
• 00810083350417 - WOLF-PACK / BIOSITE / BIOSITE PLUS: 2024-01-12 BI8004 Clear Biosite Plus Neutral Pressure Needless Valve w/14" Microbore Extension
• 00810083350387 - WOLF-PACK / BIOSITE / BIOSITE PLUS: 2024-01-12 BI8502 Opaque Biosite Plus Neutral Pressure Needless Valve w/8" Microbore Extension
• 00810083350394 - WOLF-PACK / BIOSITE / BIOSITE PLUS: 2024-01-12 BI8002 Clear Biosite Plus Neutral Pressure Needleless Valve w/8" Microbore Extension
• 00810083350400 - WOLF-PACK / BIOSITE / BIOSITE PLUS: 2024-01-12 BI8504 Opaque Biosite Plus Neutral Pressure Needleless Valve w/14" Microbore Extension
• 00810083350257 - WOLF-PACK / BIOSITE / BIOSITE PLUS: 2024-01-12 BI8000 Biosite Plus 60 psi Transparent Needleless Neutral Valve
• 00810083350370 - WOLF-PACK / BIOSITE / BIOSITE PLUS: 2024-01-12 BI8500 60 psi Transparent Needleless Neutral Valve
• 00810083350844 - BIOSITE / BIOSITE PLUS: 2024-01-12 JR-009-HU 300 psi High Pressure Needleless Neutral Valve