ONE-CUF

GUDID 00195278571359

ONE-CUF, INFANT, 1 TB BAYONET, 08 - 13 CM SINGLE

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

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• Primary Device ID: 00195278571359
• NIH Device Record Key: 8da42288-3e49-40bc-9248-fcc73e3968ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE-CUF
• Version Model Number: ONE-P1-1B
• Company DUNS: 006580799
• Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278571359 [Primary]
GS1	00195278573834 [Package]; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230145

FDA Product Code

• DXQ: Blood Pressure Cuff

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-24
• Device Publish Date: 2023-05-16

On-Brand Devices [ONE-CUF]

• 00195278571595: ONE-CUF, LARGE ADULT, 1TB BAYONET, 31 - 40 CM, SINGLE
• 00195278571588: ONE-CUF, LARGE ADULT, DINACLICK 5, 31 - 40 CM, SINGLE
• 00195278571458: ONE-CUF, ADULT LONG, 1TB BAYONET , 23 - 33 CM, SINGLE
• 00195278571427: ONE-CUF, CHILD, DINACLICK 5, 12 - 19 CM, SINGLE
• 00195278571410: ONE-CUF, ADULT, 1TB BAYONET , 23 - 33 CM, SINGLE
• 00195278571403: ONE-CUF, INFANT, DINACLICK, 08 - 13 CM SINGLE
• 00195278571397: ONE-CUF, ADULT, DINACLICK 5 , 23 - 33 CM, SINGLE
• 00195278571380: ONE-CUF, SMALL ADULT, DINACLICK 5, 17 - 25 CM, SINGLE
• 00195278571373: ONE-CUF, CHILD, 1TB BAYONET, 12 - 19 CM, SINGLE
• 00195278571366: ONE-CUF, ADULT LONG, DINACLICK 5 , 23 - 33 CM, SINGLE
• 00195278571359: ONE-CUF, INFANT, 1 TB BAYONET, 08 - 13 CM SINGLE
• 00195278571342: ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, SINGLE