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

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