Digital Telemetry Transmitter R-90347

GUDID 10841522119385

ULTRAVIEW DIG TM REFURB

SPACELABS HEALTHCARE (WASHINGTON), INC

Electrocardiography telemetric monitoring system transmitter
Primary Device ID10841522119385
NIH Device Record Key94df66b4-8be3-4b0b-96e0-795205c0773c
Commercial Distribution Discontinuation2019-03-29
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDigital Telemetry Transmitter
Version Model Number90347
Catalog NumberR-90347
Company DUNS145581588
Company NameSPACELABS HEALTHCARE (WASHINGTON), 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 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

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110841522119385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-05-07
Device Publish Date2017-01-04

On-Brand Devices [Digital Telemetry Transmitter]

10841522119385ULTRAVIEW DIG TM REFURB
10841522119224ULTRAVIEW DIG TM REFURB
10841522108709ULTRAVIEW, SYNTH, MPT, 1400MHZ, REFURBISHED
10841522108693ULTRAVIEW, SYNTH, MPT, 1400MHZ, REFURBISHED
10841522108365ULTRAVIEW DIG TM NB TX,ECG,608-614M

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