JITTO GiO Digital Pressure Gauge, -30~100 cmHO

GUDID 04710810119897

GALEMED CORPORATION

Transport electric ventilator

• Primary Device ID: 04710810119897
• NIH Device Record Key: 3cffe4b6-a5e9-4c90-ac0f-81c54432a861
• Commercial Distribution Discontinuation: 2020-04-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: JITTO
• Version Model Number: GB30
• Catalog Number: GiO Digital Pressure Gauge, -30~100 cmHO
• Company DUNS: 656854379
• Company Name: GALEMED CORPORATION
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04710810119897 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122627

FDA Product Code

• CAP: Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-21
• Device Publish Date: 2019-08-01

On-Brand Devices [JITTO]

• 44710810119901: GB40
• 44710810119899: GB30
• 44710810119888: GB20
• 44710810119871: GB10
• 44710810119895: GB30
• 04710810119897: GB30
• 04710810105258: GB30