Philips Hemodynamic Application 002010

GUDID 00884838084544

Software medical device. Intended for use by professional healthcare providers for physiologic/hemodynamic monitoring, medical data processing and analytical assessment.

Philips Medical Systems Nederland B.V.

Haemodynamic monitoring system application software

• Primary Device ID: 00884838084544
• NIH Device Record Key: bf0e6c6e-94de-4f87-93c5-b3ad99964c9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philips Hemodynamic Application
• Version Model Number: Philips Hemodynamic Application R1
• Catalog Number: 002010
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838084544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181311

FDA Product Code

• MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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: 2019-10-24
• Device Publish Date: 2018-12-01

Devices Manufactured by Philips Medical Systems Nederland B.V.

• 00884838127609 - DUNLEE SENTINELLE: 2025-01-20 ADD-ON ACCESSORIES BREAST SEN MR SET contains - 2 Fiducial Marker Grid Block Assembly and 1 BREAST GRID (USER STERILIZED)
• 00884838119277 - Philips Sentinelle: 2024-12-25 dS 1.5T Interface Box
• 00884838119284 - Philips Sentinelle: 2024-12-25 dS 3.0T Interface Box
• 00884838119291 - Philips Sentinelle: 2024-12-25 dS 1.5T 8CH Medial
• 00884838119307 - Philips Sentinelle: 2024-12-25 dS 3.0T 8CH Medial
• 00884838119314 - Philips Sentinelle: 2024-12-25 dS 1.5T 4CH Lateral Left
• 00884838119321 - Philips Sentinelle: 2024-12-25 dS 3.0T 4CH Lateral Left
• 00884838119338 - Philips Sentinelle: 2024-12-25 dS 1.5T 4CH Lateral Right