DreamMapper App iOS (APAC) 1127959

GUDID 00606959049109

DreamMapper iOS APAC Instance v 2.10

Respironics, Inc.

Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software
Primary Device ID00606959049109
NIH Device Record Key0bdc1cc9-b9ac-4ccb-acd7-e551070b33ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameDreamMapper App iOS (APAC)
Version Model Number2.10
Catalog Number1127959
Company DUNS080728314
Company NameRespironics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100606959049109 [Primary]
GS100606959049109 [Primary]
GS100606959049109 [Primary]
GS100606959049109 [Primary]
GS100606959049109 [Primary]
GS100606959049109 [Primary]
GS100606959049109 [Primary]
GS100606959049109 [Primary]
GS100606959049109 [Primary]
GS100606959049109 [Primary]
GS100606959049109 [Primary]
GS100606959049109 [Primary]
GS100606959049109 [Primary]
GS100606959049109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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 Date2020-10-15
Device Publish Date2020-10-07

On-Brand Devices [DreamMapper App iOS (APAC)]

00606959051355DreamMapper iOS APAC Instance v 2.13
00606959048584DreamMapper App iOS (APAC)
00606959049956DreamMapper iOS APAC Instance v 2.11
00606959049109DreamMapper iOS APAC Instance v 2.10

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