PATIENT CIRCUITS

GUDID 10847946023130

MASK, CPAP, #3, SM CHILD

Zoll Medical Corporation

Transport electric ventilator

• Primary Device ID: 10847946023130
• NIH Device Record Key: 1de0543f-3751-4500-abd9-6068909cafcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PATIENT CIRCUITS
• Version Model Number: 812-0008-20
• Company DUNS: 055363428
• Company Name: Zoll Medical Corporation
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• 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: false

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10847946023130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111473

FDA Product Code

• CBK: Ventilator, continuous, facility use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-16
• Device Publish Date: 2022-06-08

On-Brand Devices [PATIENT CIRCUITS]

• 10847946023208: CIRCUIT, MRI, VENT, SINGLE LIMB, INFANT
• 10847946023192: CIRCUIT, MRI, VENT, SINGLE LIMB, PED/ADULT
• 10847946023185: CIRCUIT, VENT, SINGLE LIMB, WYE, INFANT
• 10847946023178: CIRCUIT, VENT, SINGLE LIMB, WYE, ADULT/PEDI
• 10847946023161: MASK, CPAP, #6 LARGE ADULT
• 10847946023154: MASK, CPAP, #5 REGULAR ADULT
• 10847946023147: MASK, CPAP, #4, CHILD
• 10847946023123: MASK, CPAP, #2, INFANT
• 10847946023130: MASK, CPAP, #3, SM CHILD
• 00847946092856: PADDED CASE, TAN, ADULT/PEDIATRIC AND INFANT CIRCUITS, BERRY COMPLIANT