ALGO Hearing Screening Supplies 040517, 040587, 101661

GUDID 00382830046183

Jelly Tab Sensors

NATUS MEDICAL INCORPORATED

Evoked-potential audiometer
Primary Device ID00382830046183
NIH Device Record Keyb3969e98-7d2e-4e21-a57f-f5c9b30ef72d
Commercial Distribution StatusIn Commercial Distribution
Brand NameALGO Hearing Screening Supplies
Version Model NumberALGO Jelly Tab
Catalog Number040517, 040587, 101661
Company DUNS962519208
Company NameNATUS MEDICAL INCORPORATED
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-255-3901
EmailBLSC_Hearing_Support@natus.com
Phone1-800-255-3901
EmailBLSC_Hearing_Support@natus.com
Phone1-800-255-3901
EmailBLSC_Hearing_Support@natus.com
Phone1-800-255-3901
EmailBLSC_Hearing_Support@natus.com
Phone1-800-255-3901
EmailBLSC_Hearing_Support@natus.com
Phone1-800-255-3901
EmailBLSC_Hearing_Support@natus.com
Phone1-800-255-3901
EmailBLSC_Hearing_Support@natus.com
Phone1-800-255-3901
EmailBLSC_Hearing_Support@natus.com
Phone1-800-255-3901
EmailBLSC_Hearing_Support@natus.com
Phone1-800-255-3901
EmailBLSC_Hearing_Support@natus.com
Phone1-800-255-3901
EmailBLSC_Hearing_Support@natus.com
Phone1-800-255-3901
EmailBLSC_Hearing_Support@natus.com
Phone1-800-255-3901
EmailBLSC_Hearing_Support@natus.com
Phone1-800-255-3901
EmailBLSC_Hearing_Support@natus.com
Phone1-800-255-3901
EmailBLSC_Hearing_Support@natus.com
Phone1-800-255-3901
EmailBLSC_Hearing_Support@natus.com
Phone1-800-255-3901
EmailBLSC_Hearing_Support@natus.com
Phone1-800-255-3901
EmailBLSC_Hearing_Support@natus.com
Phone1-800-255-3901
EmailBLSC_Hearing_Support@natus.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100382830001045 [Package]
Package: [20 Units]
In Commercial Distribution
GS100382830044134 [Package]
Package: [40 Units]
In Commercial Distribution
GS100382830046183 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWJStimulator, Auditory, Evoked Response

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-26
Device Publish Date2016-12-30

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00382830050524 - NATUS LUMBAR EXTERNAL DRAINAGE CATHETHER2024-11-08 NATUS LUMBAR EXTERNAL DRAINAGE CATHETHER
00382830050531 - NATUS LUMBAR CATHETER KIT2024-11-08 NATUS LUMBAR CATHETER KIT
00382830050548 - NATUS EDS3 DRAINAGE SYSTEM WITH VENTRICULAR CATHETER2024-11-08 NATUS EDS3 DRAINAGE SYSTEM WITH VENTRICULAR CATHETER
00382830050555 - NATUS EDS3 DRAINAGE SYSTEM2024-11-08 NATUS EDS3 DRAINAGE SYSTEM
00382830050562 - NATUS EDS3 COLLECT BAG KIT 5 BAGS2024-11-08 NATUS EDS3 COLLECT BAG KIT 5 BAGS
00382830050579 - NATUS EDS3 LEVELING DEVICE2024-11-08 NATUS EDS3 LEVELING DEVICE
00382830050593 - NATUS EDS3 LUMBAR CATHETER KIT2024-11-08 NATUS EDS3 LUMBAR CATHETER KIT

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