Eclipse Mini 712-1053-02

GUDID 10841522130755

ECLIPSE MINI ECG SENSORS, DEFIB SAFE (BOX OF 10)

SPACELABS HEALTHCARE (WASHINGTON), INC

Electrocardiographic electrode, single-use
Primary Device ID10841522130755
NIH Device Record Key2167a6e5-122f-457b-af99-11a627639c9e
Commercial Distribution StatusIn Commercial Distribution
Brand NameEclipse Mini
Version Model NumberEclipse Mini Patches
Catalog Number712-1053-02
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110841522130755 [Primary]

FDA Product Code

DRXElectrode, electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-17
Device Publish Date2024-06-07

On-Brand Devices [Eclipse Mini]

10841522128769ECLIPSE MINI RECORDER, MULTILINGUAL
10841522129209ECLIPSE MINI RECORDER, MULTILINGUAL,LOAN
10841522130762ECLIPSE MINI ECG SENSOR, DEFIB SAFE
10841522130755ECLIPSE MINI ECG SENSORS, DEFIB SAFE (BOX OF 10)

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