EDGE SYSTEM 11996-000093

GUDID 50883873784957

Pediatric EDGE System RTS (Radiotransparent) Electrodes with QUIK-COMBO Connector

PHYSIO-CONTROL, INC.

External defibrillator electrode, paediatric, single-use External defibrillator electrode, paediatric, single-use External defibrillator electrode, paediatric, single-use External defibrillator electrode, paediatric, single-use
Primary Device ID50883873784957
NIH Device Record Keyd6316430-ea56-4cc7-a7ce-c4e85cec3629
Commercial Distribution StatusIn Commercial Distribution
Brand NameEDGE SYSTEM
Version Model Number11996
Catalog Number11996-000093
Company DUNS009251992
Company NamePHYSIO-CONTROL, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com
Phone+1(800)442-1142
Emailrs.seacustomersupport@stryker.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100721902207501 [Previous]
GS100721902207501 [Previous]
GS100721902207501 [Previous]
GS100721902207501 [Previous]
GS100883873784952 [Primary]
GS100883873784952 [Primary]
GS100883873784952 [Primary]
GS100883873784952 [Primary]
GS130883873784953 [Package]
Contains: 00883873784952
Package: pack [5 Units]
In Commercial Distribution
GS130883873784953 [Package]
Contains: 00883873784952
Package: pack [5 Units]
In Commercial Distribution
GS130883873784953 [Package]
Contains: 00883873784952
Package: pack [5 Units]
In Commercial Distribution
GS130883873784953 [Package]
Contains: 00883873784952
Package: pack [5 Units]
In Commercial Distribution
GS150883873784957 [Package]
Contains: 30883873784953
Package: case [25 Units]
In Commercial Distribution
GS150883873784957 [Package]
Contains: 30883873784953
Package: case [25 Units]
In Commercial Distribution
GS150883873784957 [Package]
Contains: 30883873784953
Package: case [25 Units]
In Commercial Distribution
GS150883873784957 [Package]
Contains: 30883873784953
Package: case [25 Units]
In Commercial Distribution

FDA Product Code

MKJAutomated external defibrillators (non-wearable)
MKJAutomated external defibrillators (non-wearable)
MKJAutomated external defibrillators (non-wearable)
MKJAutomated external defibrillators (non-wearable)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

Devices Manufactured by PHYSIO-CONTROL, INC.

50883873784957 - EDGE SYSTEM2020-11-10Pediatric EDGE System RTS (Radiotransparent) Electrodes with QUIK-COMBO Connector
50883873784957 - EDGE SYSTEM2020-11-10 Pediatric EDGE System RTS (Radiotransparent) Electrodes with QUIK-COMBO Connector
00883873867808 - NA2020-10-23 KIT, SHIPPING, SINGLE ELECTRODE, LPCR2, LL,MULTI
00883873871577 - QUIK-STEP2020-10-23 ELECTRODES, 5-YEAR, LPCR2
00883873832615 - NA2020-09-24 CABLE ASSEMBLY, 3-LEAD ECG, AHA, ROHS
00883873832622 - NA2020-09-24 CABLE ASSEMBLY, 3-LEAD ECG, IEC, ROHS
00883873832639 - NA2020-09-24 CABLE ASSY-3 WIRE ECG, AHA, LIFEPAK 1000, ROHS
00883873832646 - NA2020-09-24 CABLE ASSY-3 WIRE ECG, IEC, LIFEPAK 1000, ROHS
00883873832653 - NA2020-09-24 CABLE ASSY-5 LEAD ECG -AHA, ROHS

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