GUDID 00840682120562

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Blood pressure cuff, reusable

• Primary Device ID: 00840682120562
• NIH Device Record Key: 67115bfd-1f57-4d6f-b375-568694fdb47b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2389
• 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

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682119115 [Primary]
GS1	00840682120562 [Package]; Contains: 00840682119115; Package: [5 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: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-06-24

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

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• 00195278571342 - ONE-CUF: 2023-05-24 ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, SINGLE
• 00195278571359 - ONE-CUF: 2023-05-24 ONE-CUF, INFANT, 1 TB BAYONET, 08 - 13 CM SINGLE
• 00195278571366 - ONE-CUF: 2023-05-24 ONE-CUF, ADULT LONG, DINACLICK 5 , 23 - 33 CM, SINGLE