Extended Compact Cart, Norwegn

GUDID 00884838111714

Compact Series Ultrasound System Cart

Philips Ultrasound, Inc.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: 00884838111714
• NIH Device Record Key: 7a26489c-b3ee-456a-ac43-5eb3b7d326f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Extended Compact Cart, Norwegn
• Version Model Number: 989606735001
• Company DUNS: 063377717
• Company Name: Philips Ultrasound, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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	00884838111714 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222648

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

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: 2022-11-07
• Device Publish Date: 2022-10-28

Devices Manufactured by Philips Ultrasound, Inc.

• 00884838114241 - Affinti 50 Diaagnostic Ultrasound System Circular Edition: 2024-05-13 Software Version 10.0.2
• 00884838114258 - Affinti 70 Diaagnostic Ultrasound System Circular Edition: 2024-05-13 Software Version 10.0.2
• 00884838114203 - EPIQ 7 Diagnostic Ultrasound System Circular Edition: 2024-04-18 10.0.X Circular Edition
• 00884838114210 - EPIQ 5 Diagnostic Ultrasound System Circular Edition: 2024-04-18 10.0.X Circular Edition
• 00884838114227 - EPIQ CVx Diagnostic Ultrasound System Circular Edition: 2024-04-18 10.0.X Circular Edition
• 00884838114234 - EPIQ Elite Diagnostic Ultrasound System Circular Edition: 2024-04-18 10.0.X Circular Edition
• 00884838102729 - Transducer X11-4t: 2024-04-11
• 00884838115323 - QLAB Advanced Quantification Software: 2024-04-11