FDA.reportPublic FDA data

Nox RIP Starter Kit E, M

Primary DI
15694311110651
Brand
Nox RIP Starter Kit E, M
Company
Nox Medical ehf.
Model
NOX-EMBA1KIT2
Catalog number
558011
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CATCannula, Nasal, Oxygen
MNRVentilatory Effort Recorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1
MNRVentilatory Effort RecorderAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15694311110651PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1569431111065115694311110651

GMDN Terms#

Term, Definition table
TermDefinition
PolysomnographA mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
999-999-9999support@noxmedical.com

Regulatory Flags#

DUNS number
365741462
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15694311111887Nox Nasal Pressure Cannula with FilterNOX-MDR_CANAF405520112026-01-28
15694311111894Nox Nasal Pressure Cannula with FilterNOX-MDR_CANAF405520112026-01-28
15694311112112SomrystSOMRYST6510102024-12-30
15694311111672Nox SAS Body Cable - RightESNAP4SASRMPAC1US5622162025-06-06
15694311111689Nox SAS Body Cable - LeftESNAP4SASLMPAC1US5622172025-06-06
15694311111719Nox SAS Head CableESNAP10SASLMPAC1US5622182025-06-06
15694311111191Nox SAS Body Cable - RightESNAP4SASRMPAC1US5622162025-06-06
15694311111207Nox SAS Body Cable - LeftESNAP4SASLMPAC1US5622172025-06-06
15694311111214Nox SAS Head CableESNAP10SASLMPAC1US5622182025-06-06
15694311112099DeepRESPDEEPRESP2025-06-06
15694311112075Noxturnal WebNOXTURNAL_WEB2025-06-05
15694311110477Nox Mini USB CableNOX-USBCPAC15620112016-09-16
15694311110736QDC-PRO KitNOX-QDCPETL_KIT15140112016-09-16
15694311110354Nox Snap-on Lead, 100 cmNOX-ESNAP11PAC25540282016-09-16
15694311110361Nox Snap-on Double Lead, 50/100 cmNOX-ESNAP1PAC15543102016-09-16
15694311110378Nox Snap-on Double Lead, 30/50 cmNOX-PESNAP1PAC15543112016-09-16
15694311110279Nox Snap-on Lead, 50 cmNOX-ESNAP7PAC25540202016-09-16
15694311110286Nox Snap-on Lead, 30 cmNOX-PESNAP7PAC25540212016-09-16
15694311110316Nox Snap-on Lead, 150 cmNOX-ESNAP9PAC25540242016-09-16
15694311110323Nox Snap-on Lead, 100 cmNOX-PESNAP9PAC25540252016-09-16

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