FDA.reportPublic FDA data

NomoLine

Primary DI
10843997016787
Brand
NomoLine
Company
MASIMO CORPORATION
Model
4992
Device description
NomoLine-O HH Infant/Neonatal Airway Adapter Set, 4m
Published
2021-10-08
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
CATCANNULA, NASAL, OXYGEN

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171121000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171121000Masimo Root Monitoring System and AccessoriesMasimo Corporation2017-11-17MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843997016787PrimaryGS10
00843997016780Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084399701678710843997016787
00843997016780008439970167808439970167800843997016780

GMDN Terms#

Term, Definition table
TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(949)297-7498TechService-US@masimo.com

Regulatory Flags#

DUNS number
780421038
Device count
25
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
10843997011003Radius VSM48422026-02-23
10843997016015Radius VSM46952026-02-23
00843997019163Radius VSM90372026-02-23
00843997019019Patient SafetyNet Lite950972026-02-23
00843997011006Radius VSM48422026-02-23
00843997016018Radius VSM46952026-02-23
00843997015530Rad-G YI Multisite Reusable Sensor46532021-10-08
10843997003381LNCS26902024-08-16
10843997003398LNCS26912024-08-16
10843997003404LNCS26922024-08-16
10843997003411LNCS26942024-08-16
10843997004968MasimoSET LNCS® E1™ SpO2 Adult Pulse Oximeter Adhesive Sensor291829182016-08-24
10843997010921RD rainbow SET-240282020-09-03
10843997010938RD rainbow SET-240292020-09-03
10843997013496O343842020-09-03
00843997010825rainbow SET418341832023-02-13
00843997010818rainbow SET41822022-11-21
10843997002797MasimoSET® LNCS® Adtx-3 SpO2 Adult Pulse Oximeter Adhesive Sensor260126012016-08-24
10843997002803MasimoSET® LNCS® Pdtx-3 SpO2 Pediatric Pulse Oximeter Adhesive Sensor260226022016-08-24
10843997002810MasimoSET® LNCS® Inf-3 SpO2 Infant Pulse Oximeter Adhesive Sensor260326032016-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874950293Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874950750Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951016Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951344Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951351Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951368Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951375Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951399Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951405Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874951412Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874952075Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874952082Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954826Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954833Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954840Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954857Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954864Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954871Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954888Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
04719874954895Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19
00607411919077Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-10
00607411919091Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-10
00607411919121Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-10
00607411919084MedTronic CannulaSALTER LABSCAT2026-06-09
00607411919107Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-09
00607411919138Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-09
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