CENTRICITY PERINATAL

GUDID 00195278454386

MD CPN 6.99 MEDICAL DEVICE

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system

• Primary Device ID: 00195278454386
• NIH Device Record Key: a7dc26ac-e91d-4c92-a48c-e749c5b2a534
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CENTRICITY PERINATAL
• Version Model Number: 6.99
• Company DUNS: 006580799
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278454386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111614

FDA Product Code

• HGM: System, monitoring, perinatal

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: 2022-06-07
• Device Publish Date: 2022-05-30

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

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• 00195278341129 - Portrait CSS01: 2023-09-11 PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.0.3
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• 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