Transducer X5-1

GUDID 00884838061422

Philips Ultrasound, Inc.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00884838061422
• NIH Device Record Key: e9a18f6d-af02-4cc5-9874-111f2b78f27d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transducer X5-1
• Version Model Number: 989605400802
• 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	00884838061422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132304

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-12
• Device Publish Date: 2016-04-30

On-Brand Devices [Transducer X5-1]

• 00884838082953: 989605466031
• 00884838082946: 989605466021
• 00884838082939: 989605466011
• 00884838082922: 989605466001
• 00884838061774: 989605353783
• 00884838061422: 989605400802