FDA.reportPublic FDA data

nSpire Health

Primary DI
00852417003118
Brand
nSpire Health
Company
NSPIRE HEALTH, INC.
Model
Bronchial Challenge Kit, Disp
Catalog number
K022380
Device description
Bronchial Challenge Kit, Disposable (single patient use).
Published
2016-06-08
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
CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852417003118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852417003118008524170031188524170031180852417003118

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system delivery set, single-useA collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184817096
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
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
00850022483387Dr. Noze Best NebulizerDr. Noze Best, LLCCCQ2026-05-26
00850079671010NavägeRhinosystems, Inc.CCQ2026-03-02
14026704714527LMA ATOMIZATIONTELEFLEX INCORPORATEDCCQ2025-12-08
24026704714524LMA ATOMIZATIONTELEFLEX INCORPORATEDCCQ2025-12-08
00850024829367Shusher CarePENO LLCCCQ2025-11-03
06945040113850CONTECContec Medical Systems Co., Ltd.CCQ2025-10-13
06945040110637CONTECContec Medical Systems Co., Ltd.CCQ2025-08-12
06973134772126silverfoxSilverfox Corporation LimitedCCQ2025-01-06
00840183528423BR Surgical, LLCBR Surgical, LLCCCQ2024-11-07
00628725098203VixOne™ Nebulizer Kit Canadian Hospital Specialties LimitedCCQ2024-08-20
50628725098208VixOne™ Nebulizer Kit Canadian Hospital Specialties LimitedCCQ2024-08-20
00851440007728Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
00851440007735Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
00851440007742Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
10851440007725Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
10851440007732Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
10851440007749Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
00810094577179CuraplexBOUND TREE MEDICAL, LLCCCQ2024-07-30
00840183522018BR Surgical, LLCBR Surgical, LLCCCQ2024-07-23
00840183524128BR Surgical, LLCBR Surgical, LLCCCQ2024-07-23
00840183525255BR Surgical, LLCBR Surgical, LLCCCQ2024-07-23
00840183526689BR Surgical, LLCBR Surgical, LLCCCQ2024-07-23
06971066425639FOFOFoshan Hongfeng Co., Ltd.CCQ2024-06-06
06971066426384FOFOFoshan Hongfeng Co., Ltd.CCQ2024-06-06
06971066428340FOFOFoshan Hongfeng Co., Ltd.CCQ2024-06-06
06971066429736FOFOFoshan Hongfeng Co., Ltd.CCQ2024-06-06
06971066429439FOFOFoshan Hongfeng Co., Ltd.CCQ2024-06-05
00628725096940Nebulizer KitCanadian Hospital Specialties LimitedCCQ2024-02-23
50628725096945Nebulizer KitCanadian Hospital Specialties LimitedCCQ2024-02-23
00840117326958Resp-O2 Empty Humidifier ( Jet ) Nebulizer, 500mLDynarex CorporationCCQ2023-12-28