SOMNOscreen HD EEG 32 Set 2

Primary DI
04250413410682
Brand
SOMNOscreen HD EEG 32 Set 2
Company
SOMNOmedics GmbH
Model
NGD741U
Published
2017-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250413410682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250413410682042504134106824250413410682

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, multifunctionA small unit dedicated to the measurement and displays of several physiological parameters, e.g., electrical activity of the heart, respiratory rate, temperature, blood pressure, pulse, and oximetry. The signals are obtained through connected cables/leads/probes. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer displaying the various parameters/information measured and provided by this module.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314112173
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250413405640ABPM pro basic deviceABP050U2024-05-08
04250413402748SOMNOwatch plus ACTISOWP100Z2023-12-07
04250413402755SOMNOwatch plus ACTISOWP200Z2023-12-07
04250413410781SOMNO HD / ECO accessoryNGA3102023-11-30
04250413410828SOMNOscreen ECO EEG 32NGN740U 2023-11-30
04250413410835SOMNOtouch RESP accessoryTOS110S2023-11-30
04250413410842SOMNOtouch RESP accessoryTOS175S2023-11-30
04250413410859SOMNOtouch RESP accessoryTOS011S2023-11-30
04250413400522SOMNOscreen Plus accessorySEN614O2023-08-25
04250413400607SOMNOscreen Plus accessorySEN6132023-08-25
04250413400614SOMNOscreen Plus accessorySEN6142023-08-25
04250413400744Simplified Sleep Stage Evaluation SEP6172019-04-12
04250413401055Abdomen/Thorax Belt - Size SSEN2382019-04-12
04250413401062Abdomen/Thorax Belt - Size MSEN2392019-04-12
04250413401079Abdomen/Thorax Belt - Size LSEN2402019-04-12
04250413401086Abdomen/Thorax Belt - Size XXLSEN2282019-04-12
04250413401475SOMNOwatch plus ACTISOWP2002019-04-12
04250413401666SOMNOwatch plus Docking StationSOW1062019-04-12
04250413401673PLM Sensor Set (Activity)SOW1152019-04-12
04250413401680PLM Sensor Set SOW1162019-04-12