nSpire Health K004300

GUDID 00852417003446

All-digital, tempered glass and metal body plethysmograph features fail-safe automatic release of the cabin door locking mechanism, patient intercom, and motorized sensor arm, providing superior performance, patient comfort and convenience.

NSPIRE HEALTH, INC.

Whole-body plethysmograph
Primary Device ID00852417003446
NIH Device Record Key697d70e3-52f4-4ac7-bc63-75cfc411ef95
Commercial Distribution StatusIn Commercial Distribution
Brand NamenSpire Health
Version Model NumberBpD
Catalog NumberK004300
Company DUNS184817096
Company NameNSPIRE HEALTH, 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 Batchfalse
Serial Numbertrue
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
GS100852417003446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CCMPlethysmograph, Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-12-28

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