AccuSom

Primary DI
00860512000215
Brand
AccuSom
Company
NOVASOM, INC.
Model
NS2010
Device description
Chain of Custody Patient Interface Dongle
Published
2020-02-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860512000215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860512000215008605120002158605120002150860512000215

GMDN Terms#

Term, Definition table
TermDefinition
Home-use sleep apnoea recording systemA battery-powered device intended to continuously measure and record patient physiological parameters (e.g., arterial oxygen saturation level, pulse rate, respiration effort, airflow waveform) during sleep in the home, to facilitate the diagnosis of sleep apnoea. It typically consists of multiple components including a control unit which may have some user-interface functionality, sensors, and connecting leads, which record parameters and may upload the data to a central analysis system.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4105901823hnull@novasom.com

Regulatory Flags#

DUNS number
808379150
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860512000260AccuSom1017-15004-US2023-01-13
00860512000277AccuSom1017-15014-US2023-01-13
00860512000291AccuSom1017-50003-US2023-01-13
00860512000253AccuSom1017-10001-US2023-01-13
00860512000222AccuSomNS20102020-03-03
00860512000239AccuSomNS20102020-03-03
00860512000246AccuSomNS20102020-03-03
00860512000208AccuSomNS20102016-11-30