AccessGUDID - DEVICE: LIFEPAK CR2 (00883873824061)

GUDID

Device Identifier (DI) Information

Brand Name: LIFEPAK CR2
Version or Model: 99512
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 99512-001268
Company Name: PHYSIO-CONTROL, INC.

Primary DI Number: 00883873824061
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009251992 *Terms of Use

Device Description: CR2BBAAADDHBBBCDBCDBAAAALPCR2 CONFIGURED UNIT

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
48047	Non-rechargeable public automated external defibrillator	A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it automatically activates defibrillation of the heart through application of electrical shocks to the chest surface. The device is placed in conspicuous public locations and is intended to be applied to the patient by a layperson. It consists of an external pulse generator (EPG) with a cardiac rhythm recognition system and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it also includes a non-rechargeable battery for energy.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKJ	Automated external defibrillators (non-wearable)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P170018	002
P170018	003

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: 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.
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 15 and 35 Degrees Celsius
Handling Environment Temperature: between -30 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a9df5310-1828-495e-99ab-7d85683faae7
Public Version Date: May 18, 2020
Public Version Number: 2
DI Record Publish Date: January 08, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)442-1142
Email: rs.seacustomersupport@stryker.com

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