Breas iSleep 20i system 207000

GUDID 07321822070167

Home CPAP unit

Primary Device ID	07321822070167
NIH Device Record Key	6adde063-2d34-4293-a816-f5259869e7d8
Commercial Distribution Status	In Commercial Distribution
Brand Name	Breas iSleep 20i system
Version Model Number	US
Catalog Number	207000
Company DUNS	357007657
Company Name	Breas Medical AB
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	true
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 Issuing Agency	Device ID
GS1	07321822070006 [Primary]
GS1	07321822070167 [Package] Contains: 07321822070006 Package: Box [1 Units] In Commercial Distribution

BZD	Ventilator, Non-Continuous (Respirator)

Steralize Prior To Use	false
Device Is Sterile	false

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