OBIX Perinatal Data System

GUDID 00868102000416

OBIX Perinatal Data System is used in perinatal areas of the hospital (L&D, PP, Antepartum, Triage). A patient record is populated with information related to perinatal fetal monitor surveillance.

Clinical Computer Systems, Inc.

Patient health record information system application software

• Primary Device ID: 00868102000416
• NIH Device Record Key: e47261e4-9c53-4717-8aae-31c0543f5fdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OBIX Perinatal Data System
• Version Model Number: 10.0
• Company DUNS: 928008213
• Company Name: Clinical Computer Systems, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868102000416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121208

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: 2021-07-29
• Device Publish Date: 2021-07-21

On-Brand Devices [OBIX Perinatal Data System]

• 00868102000423: OBIX Perinatal Data System is used in perinatal areas of the hospital (L&D, PP, Antepartum, Tria
• 00868102000416: OBIX Perinatal Data System is used in perinatal areas of the hospital (L&D, PP, Antepartum, Tria
• 00868102000447: OBIX Perinatal Data System is used in perinatal areas of the hospital (L&D, PP, Antepartum, Tria