Sensor

GUDID 00847946021689

MODULE, CAPNO 5 LOFLO, ETCO2

Zoll Medical Corporation

Rechargeable professional automated external defibrillator

• Primary Device ID: 00847946021689
• NIH Device Record Key: b7bd0280-668d-44c6-9e50-59ce51d199d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sensor
• Version Model Number: 9355-0367
• 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: 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: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling 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	00847946021689 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120907

FDA Product Code

• CCK: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

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: 2016-09-16

On-Brand Devices [Sensor]

• 00847946021689: MODULE, CAPNO 5 LOFLO, ETCO2
• 00847946021672: SENSOR, CAPNOSTAT 5, E SERIES
• 00847946021283: DEVICE IDENTIFIER SENSOR, CAPNOSTAT III
• 00847946021269: MAINSTREAM - CAPNO 5 CO2 SENSOR AND CABLE
• 00847946024215: SENSOR, CAPNOSTAT 5, E SERIES