FDA.reportPublic FDA data

miniFlow

Primary DI
00853678006597
Brand
miniFlow
Company
AIRON CORPORATION
Model
58422
Catalog number
58422
Device description
Attachment Strip for bonnets, size 20 cm, single patient use 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
K121379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121379000PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORYAiron Corporation2012-10-11CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853678006603PackageGS110In Commercial Distribution
00853678006597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853678006603008536780066038536780066030853678006603
00853678006597008536780065978536780065970853678006597

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP nasal mask, single-useA non-sterile, flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0.1Inch
Length7.9Inch
Weight0.000625Pound
Width0.25Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-22 Degrees Fahrenheit158 Degrees Fahrenheit
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-22 Degrees Fahrenheit158 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
015222912
Device count
1
Lot or batch
true
Manufacturing date on label
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
00853678006054pNeuton58001580012016-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814747025239Novaplus Full Face AAV Non Vented Mask, Extra LargeSLEEPNET, CORP.CBK2026-10-23
00814747025246Novaplus Full Face AAV Non Vented Mask, LargeSLEEPNET, CORP.CBK2026-10-23
00814747025253Novaplus Full Face AAV Non Vented Mask, MediumSLEEPNET, CORP.CBK2026-10-23
00814747025260Novaplus Full Face AAV Non Vented Mask, SmallSLEEPNET, CORP.CBK2026-10-23
00814747025277Novaplus Full Face Non Vented Mask, Extra LargeSLEEPNET, CORP.CBK2026-10-23
00814747025284Novaplus Full Face Non Vented Mask, LargeSLEEPNET, CORP.CBK2026-10-23
00814747025291Novaplus Full Face Non Vented Mask, MediumSLEEPNET, CORP.CBK2026-10-23
00814747025307Novaplus Full Face Non Vented Mask, SmallSLEEPNET, CORP.CBK2026-10-23
00198843006454LTVZoll Medical CorporationCBK2026-09-18
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