FDA.reportPublic FDA data

Hudson RCI

Primary DI
10852417003221
Brand
Hudson RCI
Company
NSPIRE HEALTH, INC.
Model
Pocket Chamber
Catalog number
1001-10
Device description
Pocket Chamber Anti-Static Valved Aerosol Holding Chamber 10-Pack.
Published
2016-09-20
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
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993199000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993199000POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBERFerraris Medical, Inc.2000-03-28CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852417003221PrimaryGS10
00852417003224Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085241700322110852417003221
00852417003224008524170032248524170032240852417003224

GMDN Terms#

Term, Definition table
TermDefinition
Medicine chamber spacer, reusableA device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. It is typically made of plastic materials and in the form of a small tube-like container. By holding the drug(s) after aerosolization (e.g., via an internal valve) this device reduces the direct delivery of large aerosolized particles which would otherwise deposit in the mouth/upper airway, but are intended for the lower airway. This is a reusable device.

Regulatory Flags#

DUNS number
184817096
Device count
10
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
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
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
10852417003740nSpire HealthKoKo Filter8770002016-09-16

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Primary DI, Brand, Company table
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10197344137244HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-04-11
10197344006014HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-02-21
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
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10197344006021HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2023-12-15
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