LIFEPAK CR2 99512-001261

GUDID 00883873824139

CR2BAAAABFHBBBCDBCDBAAAA

PHYSIO-CONTROL, INC.

Non-rechargeable public semi-automated external defibrillator
Primary Device ID00883873824139
NIH Device Record Keycfc8e789-3a09-425a-ab35-0384054a3ca8
Commercial Distribution StatusIn Commercial Distribution
Brand NameLIFEPAK CR2
Version Model Number99512
Catalog Number99512-001261
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
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 60 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *ALTHOUGH DESIGNED FOR A RANGE OF -30 TO 60 C (-22 TO 140 F), STORAGE AT THESE EXTREMES IS LIMITED TO ONE WEEK. STORAGE PAST THAT TIME WILL REDUCE THE ELECTRODE SHELF-LIFE AND BATTERY LIFE.
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *ALTHOUGH DESIGNED FOR A RANGE OF -30 TO 60 C (-22 TO 140 F), STORAGE AT THESE EXTREMES IS LIMITED TO ONE WEEK. STORAGE PAST THAT TIME WILL REDUCE THE ELECTRODE SHELF-LIFE AND BATTERY LIFE.
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *ALTHOUGH DESIGNED FOR A RANGE OF -30 TO 60 C (-22 TO 140 F), STORAGE AT THESE EXTREMES IS LIMITED TO ONE WEEK. STORAGE PAST THAT TIME WILL REDUCE THE ELECTRODE SHELF-LIFE AND BATTERY LIFE.
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100883873824139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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 Date2019-02-08
Device Publish Date2019-01-08

On-Brand Devices [LIFEPAK CR2]

00883873824139CR2BAAAABFHBBBCDBCDBAAAA
00883873824122CR2BBAAABFHBBBCDBCDBAAAA
00883873824115CR2BAAAABBHBBBCDBCDBAAAA
00883873824108CR2BBAAABBHBBBCDBCDBAAAA
00883873824092CR2BAAAADHHBBBCDBCDBAAAA
00883873824085CR2BBAAADHHBBBCDBCDBAAAA
00883873824078CR2BAAAADDHBBBCDBCDBAAAA
00883873824061CR2BBAAADDHBBBCDBCDBAAAA

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