Philips health band

GUDID 20075020067160

DL7421/21

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	20075020067160
NIH Device Record Key	f01340b5-4e66-4b6c-b5bd-a65b251b49f2
Commercial Distribution Status	In Commercial Distribution
Brand Name	Philips health band
Version Model Number	DL7421
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	00075020066800 [Primary]
GS1	10075020009897 [Package] Contains: 00075020066800 Package: [2 Units] In Commercial Distribution
GS1	20075020067160 [Package] Contains: 10075020009897 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

On-Brand Devices [Philips health band]

20075020067184	DL7422/11
20075020067160	DL7421/21
00075020066794	DL7421/11