MY-CUF

GUDID 00840682116947

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Blood pressure cuff, single-use

• Primary Device ID: 00840682116947
• NIH Device Record Key: 0c44d7d8-630c-4854-96ee-a359f97fe969
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MY-CUF
• Version Model Number: MY-T1-2A
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

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	00840682116220 [Primary]
GS1	00840682116947 [Package]; Contains: 00840682116220; Package: [20 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-15

On-Brand Devices [MY-CUF]

• 00840682116954: MY-P1-2A
• 00840682116466: MY-A3-1B
• 00840682116893: MY-A2-2E-L
• 00840682116930: MY-P1-2C
• 00840682116497: MY-T1-1B
• 00840682116435: MY-A1-2C
• 00840682120920: MY-A2-2A
• 00840682120913: MY-A2-2C-L
• 00840682116381: MY-P1-1B
• 00840682120876: MY-A3-2E
• 00840682116947: MY-T1-2A
• 00840682116428: MY-A1-2A
• 00840682116374: MY-T1-2E
• 00840682120890: MY-T1-2C
• 00840682116961: MY-A3-2C
• 00840682120944: MY-P2-2C
• 00840682120883: MY-P2-2A
• 00840682116459: MY-A2-1B-L
• 00840682120968: MY-P2-2E
• 00840682120951: MY-P1-2E
• 00840682116916: MY-A3-2A
• 00840682120937: MY-A2-2E
• 00840682120906: MY-A1-2E
• 00840682116480: MY-P2-1B
• 00840682116411: MY-A2-1B
• 00840682116909: MY-A2-2C
• 00840682116923: MY-A2-2A-L
• 00840682116398: MY-A1-1B