Phlips health band

GUDID 20075020067177

DL7422/21

Philips Medical Systems Nederland B.V.

Photoplethysmography/accelerometery recording sensor Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder

• Primary Device ID: 20075020067177
• NIH Device Record Key: 24024805-6374-4c38-9212-103e43c1d264
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phlips health band
• Version Model Number: DL7422
• Company DUNS: 489844773
• Company Name: Philips Medical Systems Nederland B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00075020066824 [Primary]
GS1	10075020009903 [Package]; Contains: 00075020066824; Package: [2 Units]; In Commercial Distribution
GS1	20075020067177 [Package]; Contains: 10075020009903; Package: [4 Units]; In Commercial Distribution

FDA Product Code

• ISD: Exerciser, Measuring

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: 2019-11-08
• Device Publish Date: 2017-06-14

Devices Manufactured by Philips Medical Systems Nederland B.V.

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• 00884838099203 - Azurion: 2023-09-26 Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 12-inch flat detector.
• 00884838099210 - Azurion: 2023-09-26 Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 15-inch flat detector.