GUDID 00840682119986

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Blood pressure cuff, reusable

• Primary Device ID: 00840682119986
• NIH Device Record Key: db91c134-ac0f-4dfd-bfee-300081a967eb
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2059291-003
• Company DUNS: 784985108
• Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Humidity: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682118903 [Primary]
GS1	00840682119986 [Package]; Contains: 00840682118903; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120125

FDA Product Code

• DXQ: blood pressure cuff

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-06-30

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