Somanetics

GUDID 30817357022194

Cerebral/Somatic Oximetry Pediatric Sensor

HYGIA HEALTH SERVICES, INC.

Tissue saturation oximeter sensor, reprocessed
Primary Device ID30817357022194
NIH Device Record Keyc6a8d710-7d78-45d0-8d40-2da70aa75526
Commercial Distribution Discontinuation2019-07-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSomanetics
Version Model NumberSPFB-USA
Company DUNS177939027
Company NameHYGIA HEALTH SERVICES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110817357022190 [Primary]
GS130817357022194 [Package]
Contains: 10817357022190
Package: Box [20 Units]
Discontinued: 2021-03-19
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NMDOximeter, Tissue Saturation, Reprocessed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-03-19
Device Publish Date2017-02-04

On-Brand Devices [Somanetics]

30817357022194Cerebral/Somatic Oximetry Pediatric Sensor
30817357020541Cerebral/Somatic Oximetry Adult Sensor 

Trademark Results [Somanetics]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOMANETICS
SOMANETICS
73422113 1345190 Dead/Cancelled
SOMANETICS CORPORATION
1983-04-18
SOMANETICS
SOMANETICS
73421958 1315595 Live/Registered
Somanetics Corporation
1983-04-18

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