FDA.reportPublic FDA data

nSpire Health

Primary DI
10852417003696
Brand
nSpire Health
Company
NSPIRE HEALTH, INC.
Model
KoKo Filter Kit
Catalog number
K022465
Device description
KoKo Standard White Filter Kit with Nose Clip and Rubber Mouthpiece for use with KoKo Px, HDpft, and Collins. Box of 100.
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BXJClip, Nose
BYPMouthpiece, Breathing
CAHFilter, Bacterial, Breathing-Circuit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXJClip, NoseAnesthesiology1
BYPMouthpiece, BreathingAnesthesiology1
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852417003696PrimaryGS10
00852417003699Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085241700369610852417003696
00852417003699008524170036998524170036990852417003699

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function testing kitA collection of non-sterile devices intended to be used in conjunction with pulmonary function analysis equipment to perform a pulmonary function test. It may include a breathing mouthpiece, filter (intended to reduce contamination of parent device), and a nose clip. This is a single-use device.

Regulatory Flags#

DUNS number
184817096
Device count
100
Kit
true
Lot or batch
true
Expiration date on label
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
08697645018150ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018167ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018174ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018181ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08904461055031OSSEOUS-SnorOFFEON MEDITECH PRIVATE LIMITEDBYP2026-03-13
10197344157938MEDLINEMEDLINE INDUSTRIES, INC.CAH2025-09-12
10197344157945MEDLINEMEDLINE INDUSTRIES, INC.CAH2025-09-12
10197344011315HUDSON RCIMEDLINE INDUSTRIES, INC.BYP2025-08-18
07613365500127SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
07613365500141SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
07613365500202SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
07640142190233spiretteNDD Medizintechnik AGBYP2023-06-23
07640142190240spiretteNDD Medizintechnik AGBYP2023-06-23
07640142190271spirette mNDD Medizintechnik AGBYP2023-06-23
07640142190653spirette FA Pro/LABNDD Medizintechnik AGBYP2023-06-23
07640142190660spirette FA Pro/LABNDD Medizintechnik AGBYP2023-06-23
07640142190684spirette FA Pro/LABNDD Medizintechnik AGBYP2023-06-23
07640142190400spiretteNDD Medizintechnik AGBYP2023-06-22
07640142190448EasyOne FlowTubeNDD Medizintechnik AGBYP2023-06-22
07640142190455EasyOne FlowTubeNDD Medizintechnik AGBYP2023-06-22
07640142190608Filter Adapter SPNDD Medizintechnik AGBYP2023-06-22
07640142190615Filter Adapter FTNDD Medizintechnik AGBYP2023-06-22
07640142190882EasyOne Filter SPNDD Medizintechnik AGCAH2022-12-09
07640142190899EasyOne Filter FTNDD Medizintechnik AGCAH2022-12-09
10193489339826Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAH2022-08-04
10193489139990MedlineMEDLINE INDUSTRIES, INC.CAH2022-08-03
09420012432339Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAH2022-08-02
10193489085600MedlineMEDLINE INDUSTRIES, INC.CAH2022-07-12
10193489025019MedlineMEDLINE INDUSTRIES, INC.CAH2022-06-10
10193489019452HYDRO-GUARD MINI BREATHING FILTER Intersurgical IncorporatedCAH2021-10-05