DreamStation 2 BLX410H15C

GUDID 00606959062849

DreamStation 2 CPAP with humidifier, cellular, bluetooth for BL

Respironics, Inc.

Home CPAP unit
Primary Device ID00606959062849
NIH Device Record Key79bae814-3cfc-45df-9526-8a0d3f714bc7
Commercial Distribution StatusIn Commercial Distribution
Brand NameDreamStation 2
Version Model Number00
Catalog NumberBLX410H15C
Company DUNS080728314
Company NameRespironics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959062849 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-07
Device Publish Date2021-03-30

On-Brand Devices [DreamStation 2]

00606959062757DreamStation 2 ADVANCED Auto CPAP device with Humidifier, Flex Features, Cellular Bluetooth Conn
00606959062849DreamStation 2 CPAP with humidifier, cellular, bluetooth for BL
00606959062832DreamStation 2 Auto CPAP with humidifier, cellular, bluetooth for BL
00606959062825DreamStation 2 Advanced CPAP with humidifier, cellular, bluetooth for BL
00606959062818DreamStation 2 Advanced Auto CPAP with Humidifier, Cellular, Bluetooth for BL
00606959063099DreamStation2 Auto CPAP Advanced with Hu
00606959063228DreamStation 2 CPAP w/ Humidifier/Cell/B
00606959063082DreamStation 2 Auto CPAP Advanced w/ Hum

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