FDA.reportPublic FDA data

Neurovirtual

Primary DI
00850008393389
Brand
Neurovirtual
Company
NEUROVIRTUAL USA, INC.
Model
Maxxi Cannula 7ft Adult Nasal
Catalog number
SI1058
Device description
Maxxi Cannula is a two-pronged device used to acquire breathing pressure to sleep testing device through both nostrils for sleep disorder studies.
Published
2023-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CATCannula, Nasal, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850008393389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008393389008500083933898500083933890850008393389

GMDN Terms#

Term, Definition table
TermDefinition
Nasal oxygen cannula, basicA semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature40 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
791140622
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008393358Neurovirtual"Maxxi Gold AgCl Electrode 60"" Reusable"SI21372022-02-01
00850008393365Neurovirtual"Maxxi Gold AgCl Electrode 96"""SI21382022-02-01
00850008393303Neurovirtual"Maxxi Gold AgCl Electrode 60"""SI20362020-08-10
00850008393310Neurovirtual"Maxxi Gold AgCl Electrode 96"""SI20372020-08-10
00867975000295Neurovirtual"Maxxi Gold Electrode 60"""PV1010-13CI2019-11-26
00850008393006Neurovirtual"Maxxi Gold Electrode 96"""PV1010-23CI2019-11-26
00850008393013Neurovirtual"Maxxi Gold Snap Electrode 96"""SI18782019-11-26
00850008393020Neurovirtual"Maxxi Gold Snap Electrode 60"""SI18732019-11-26
00850008393037Neurovirtual"Maxxi Gold Snap Electrode 48"""SI18722019-11-26
00850008393044Neurovirtual"Maxxi Gold Electrode 48"""PV1010-33CI2019-11-26
00850008393228NeurovirtualBWMini PSGPV23112019-11-26
00850008393235NeurovirtualBWMini EEGPV23102019-11-26
00850008393242NeurovirtualBWMini HSTPV23122019-11-26
00850008393259NeurovirtualBWMini HST CompassSI18422019-11-26
00850008393372NeurovirtualMaxxi Cannula 2ft Adult NasalSI11952023-03-03
00850008393396NeurovirtualMaxxi Cannula 7ft Adult NasalSI10572023-03-03
00850008393174NeurovirtualBWIII BasicsPV20102019-11-26
00850008393181NeurovirtualBWIII EEGPV20062019-11-26
00850008393198NeurovirtualBWIII EEG PlusPV20072019-11-26
00850008393211NeurovirtualBWIII PSG PlusPV20092019-11-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344155125MEDLINEMEDLINE INDUSTRIES, INC.CAT2026-01-29
10197344158478HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-10-17
10197344158409HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158416HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158423HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158430HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158447HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158454HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158461HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161164MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161171MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161188MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161195MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161201MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161218MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161225MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161232MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344155064MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-08-21
10197344155101MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-08-21
10197344158522MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-08-21
10197344009664HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344009985HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344010004HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344011254HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344011261HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344042210HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344042227HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344102099MEDLINEMEDLINE INDUSTRIES, INC.CAT2024-08-15
10197344099832MEDLINEMEDLINE INDUSTRIES, INC.CAT2024-08-07
10197344099849MEDLINEMEDLINE INDUSTRIES, INC.CAT2024-08-07