Digital Telemetry Transmitter R-91347-09

GUDID 10841522108709

ULTRAVIEW, SYNTH, MPT, 1400MHZ, REFURBISHED

SPACELABS HEALTHCARE (WASHINGTON), INC

Electrocardiography telemetric monitoring system transmitter
Primary Device ID10841522108709
NIH Device Record Key5b059692-6045-4fd3-ae96-c20e89a348ce
Commercial Distribution Discontinuation2019-03-29
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDigital Telemetry Transmitter
Version Model Number91343
Catalog NumberR-91347-09
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 TemperatureBetween -40 Degrees Celsius and 75 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 75 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110841522108709 [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 Date2016-12-20

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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