Mothership Wireless Fetal Transducer Base Station

GUDID 00852189007376

Mothership Wireless Fetal Transducer Base Station

TENACORE HOLDINGS, INC.

Cardiotocography telemetric monitoring system receiver
Primary Device ID00852189007376
NIH Device Record Key7a6c9e20-31b1-46d5-95a1-2d2598614912
Commercial Distribution StatusIn Commercial Distribution
Brand NameMothership Wireless Fetal Transducer Base Station
Version Model NumberF1
Company DUNS138781799
Company NameTENACORE HOLDINGS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100852189007376 [Primary]

FDA Product Code

HGMSystem, Monitoring, Perinatal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-10-16

Devices Manufactured by TENACORE HOLDINGS, INC.

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