FDA.reportPublic FDA data

pNeuton

Primary DI
00853678006054
Brand
pNeuton
Company
AIRON CORPORATION
Model
58001
Catalog number
58001
Device description
Adult / pediatric patient circuit, disposable, single patient use, 6 feet long, each
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K024344000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024344000PNEUTON VENTILATORAiron Corporation2003-06-03CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853678006061PackageGS115In Commercial Distribution
00853678006054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853678006061008536780060618536780060610853678006061
00853678006054008536780060548536780060540853678006054

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, single-useAn assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0.86Inch
Length72Inch
Weight0.3125Pound
Width0.86Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature23 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
321-821-9433info@aironusa.com

Regulatory Flags#

DUNS number
015222912
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853678006733pNeuton Model A with 6ft Patient CircuitA200592025-12-19
00853678006726pNeuton Model A Start-up Kit with 8ft Patient CircuitA200602025-12-18
00853678006078MACS58011580112016-09-24
00853678006139pNeuton58035580352016-09-24
00853678006634pNeuton58006580062016-09-24
00853678006658MACS58021580212016-09-24
00853678006696pNeuton58201582012019-06-17
00853678006092pNeuton58051580512016-09-24
00853678006115pNeuton58031580312016-09-24
00853678006252miniFlow58406584062016-09-24
00853678006276miniFlow58405584052016-09-24
00853678006290miniFlow58404584042016-09-24
00853678006313miniFlow58403584032016-09-24
00853678006337miniFlow58402584022016-09-24
00853678006351miniFlow58401584012016-09-24
00853678006375miniFlow58400584002016-09-24
00853678006238miniFlow58407584072016-09-24
00853678006672pNeuton58210582102017-01-10
00853678006689pNeuton58210582102017-01-10
00853678006061pNeuton58001580012016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344102655MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
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10197344102686MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102693MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102709MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
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09420012480446F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480460F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
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