AccessGUDID - DEVICE: TrueCPR™ Coaching Device (00883873890455)

GUDID

Device Identifier (DI) Information

Brand Name: TrueCPR™ Coaching Device
Version or Model: 80596
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80596-000003
Company Name: PHYSIO-CONTROL, INC.

Primary DI Number: 00883873890455
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009251992 *Terms of Use

Device Description: TRUECPR,PACKAGED,MULTI-LANGUAGE, CONFIG B

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?
60368	Cardiopulmonary resuscitation feedback device, electronic	A portable, battery-powered device intended to provide real-time feedback on manual chest compressions (i.e., depth of compression) performed during cardiopulmonary resuscitation (CPR) on a patient in cardiac arrest, or during training on a resuscitation training model. It typically consists of a chest plate with a digital display, which is placed on the sternum and pushed down during chest compressions and will display compression depth and rate, measured by one of various electronic technologies (e.g., electromagnetic signaling to a baseplate, accelerometer). It is intended to be used by those trained in CPR.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LIX	AID, CARDIOPULMONARY RESUSCITATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: abd7e219-fcc4-44dc-9b0d-3eebdecc9c93
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 11, 2014