FDA.reportPublic FDA data

nSpire Health

Primary DI
00852417003446
Brand
nSpire Health
Company
NSPIRE HEALTH, INC.
Model
BpD
Catalog number
K004300
Device description
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.
Published
2017-12-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CCMPlethysmograph, Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCMPlethysmograph, PressureAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K852102000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K852102000COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEMWarren E. Collins, Inc.1985-07-31CCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852417003446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852417003446008524170034468524170034460852417003446

GMDN Terms#

Term, Definition table
TermDefinition
Whole-body plethysmographA graphic recorder designed for determining and registering airway resistance and thoracic gas volume to assess pulmonary function. It includes an airtight body chamber and transducers that allow the recording of chamber pressure versus airflow, and chamber pressure versus mouth pressure, to determine the airway resistance. Thoracic gas volume is typically determined by recording the chamber and airway pressures simultaneously with the airway open and with the airway occluded. It may also be possible to determine the instantaneous flow by recording the pulmonary capillary blood flow with the device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184817096
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852417003316nSpire HealthKoKo Sx 1000 Diagnostic Spirometer Standalone Edit3131202017-01-24
00852417003347nSpire HealthKoKo Sx 1000 Diagnostic SpirometerSX10002017-01-24
00852417003354nSpire HealthKoKo Legend II3150002016-09-15
00852417003361nSpire HealthKoKo Legend II3150022016-09-15
00852417003385nSpire HealthKoKo Px 2000 Pulmonary Function Testing SystemPX20002016-09-16
00852417003453nSpire HealthKoKo Px 2000 Pulmonary Function Test System4006002018-12-14
00852417003460nSpire HealthKoKo Px 3000 Pulmonary Function Testing System4006012018-12-14
00852417003477nSpire HealthKoKo Px 4000 Pulmonary Function Testing System4006022018-12-14
00852417003484nSpire HealthKoKo Px 4000N Pulmonary Function Testing System4006032018-12-14
10852417003207Hudson RCIPocket Peak Flow Meter18012016-09-20
10852417003221Hudson RCIPocket Chamber1001-102016-09-20
10852417003573nSpire HealthKoKo Filter 9110002016-09-16
10852417003580nSpire HealthKoKo Filter9160002016-09-16
10852417003597nSpire HealthKoKo Filter9150002016-09-16
10852417003603nSpire HealthKoKo Filter8100002016-09-16
10852417003634nSpire HealthKoKo Filter8110002016-09-16
10852417003641nSpire HealthKoKo Filter8150002016-09-16
10852417003672nSpire HealthKoKo FilterK0224542016-09-16
10852417003702nSpire HealthKoKo Filter8310002016-09-16
10852417003726nSpire HealthKoKo Filter8510002016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250892908823JaegerJaeger Medical GmbHCCM2025-11-24
14250892908905JaegerJaeger Medical GmbHCCM2025-11-24
14250892907045JaegerJaeger Medical GmbHCCM2025-08-14
14250892907052JaegerJaeger Medical GmbHCCM2025-08-14
14250892907069JaegerJaeger Medical GmbHCCM2025-08-14
14250892907519JaegerJaeger Medical GmbHCCM2025-07-23
14250892906260VyaireJaeger Medical GmbHCCM2023-01-03
14250892906185VyaireJaeger Medical GmbHCCM2021-07-16
14250892906192VyaireJaeger Medical GmbHCCM2021-07-16
14250892906239VyaireJaeger Medical GmbHCCM2021-07-16
14250892906161VyaireJaeger Medical GmbHCCM2021-06-10
14250892906178VyaireJaeger Medical GmbHCCM2021-06-10
00852417003514KoKo, LLCKoko, LLCCCM2021-04-16
14250892903696VyaireJaeger Medical GmbHCCM2019-06-04
04250892905006JaegerJaeger Medical GmbHCCM2019-03-20
14250892903337VyaireJaeger Medical GmbHCCM2019-03-19
14250892903344VyaireJaeger Medical GmbHCCM2019-03-19
14250892903351VyaireJaeger Medical GmbHCCM2019-03-19
14250892904259VyaireJaeger Medical GmbHCCM2019-03-19
14250892904518VyaireJaeger Medical GmbHCCM2019-03-19
04250892904993JaegerJaeger Medical GmbHCCM2019-03-19
04250892905013JaegerJaeger Medical GmbHCCM2019-03-19
04250892905020JaegerJaeger Medical GmbHCCM2019-03-19
00810016250234MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONCCM2019-02-22
00810016250418MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONCCM2019-02-22
00810016250241MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONCCM2019-02-22
04250892902692JaegerJaeger Medical GmbHCCM2019-01-24
04250892902708JaegerJaeger Medical GmbHCCM2019-01-24
14250892902460JaegerJaeger Medical GmbHCCM2018-09-30
14250892902507JaegerJaeger Medical GmbHCCM2018-09-21