Digital Telemetry 012-0284-11

GUDID 10841522100680

LDWR SET,PINCH,DIN,61CM/ 24 IN,AAMI,3LW/ST, 1/ST

SPACELABS HEALTHCARE (WASHINGTON), INC

Electrocardiographic lead set, reusable
Primary Device ID10841522100680
NIH Device Record Key9354824a-7f75-4d22-9e69-a747d495a5e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameDigital Telemetry
Version Model Number90347
Catalog Number012-0284-11
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110841522100680 [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 Number7
Public Version Date2020-03-17
Device Publish Date2017-03-07

Devices Manufactured by SPACELABS HEALTHCARE (WASHINGTON), INC

10841522129216 - Spacelabs2024-08-26 SMART ALARM INTERFACE (SAI)
30841522126417 - Trulink2024-07-24 CO2 SAMPLE LINE W/MALE LUER
10841522129773 - Lifescreen Pro2024-07-24 SENTINEL/LIFESCREEN PRO RAPID ANALYSIS KIT EN
30841522125618 - Spacelabs Healthcare2024-07-23 4-ELECTRODE HOOK UP KIT WITH POUCH
10841522131141 - Xhibit2024-07-12 DISPLAY,21.5",CAPACITIVE TOUCH,BLACK,ANTI-GLARE
10841522100710 - SENTINEL2024-07-03 SENTINEL
10841522117688 - XHIBIT2024-06-17 CENTRAL STATION,96102,REFURBISHED
10841522124662 - Trulink2024-06-17 CABLE,ECG,UN-SHLD,NEO,3-LEAD,305CM/10 FT,AAMI

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