Transducer PA4-2

GUDID 00884838024649

Philips Ultrasound, Inc.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00884838024649
• NIH Device Record Key: 1432085a-3a0b-47a5-bf3d-fcbead283482
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transducer PA4-2
• Version Model Number: 21422A
• Company DUNS: 063377717
• Company Name: Philips Ultrasound, 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838024649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030455

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

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: 2019-09-30
• Device Publish Date: 2016-10-28

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• 00884838120266 - Lumify Diagnostic Ultrasound System iOS: 2023-08-08 Release 5.0 iOS
• 00884838121423 - TOMTEC ARENA: 2023-07-27
• 00088483810859 - Transducer mL26-8: 2023-05-30
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• 00884838114111 - EPIQ 5 Diagnostic Ultrasound System: 2023-05-17 Software version-10.0.X