AccessGUDID - DEVICE: PHILIPS HeartStart Configure (00884838041547)

GUDID

Device Identifier (DI) Information

Brand Name: PHILIPS HeartStart Configure
Version or Model: HeartStart Configure
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 861487
Company Name: PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

Primary DI Number: 00884838041547
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079503890 *Terms of Use

Device Description: HeartStart Configure

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	No
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?
44083	Emergency/ambulatory healthcare software	A software program intended to support the administrative and clinical activities associated with the provision and utilization of emergency medical services (EMS), emergency social services (ESS), and/or public safety facilities. It typically allows for communication of patient physiological data to facilitate activities such as on-line consultation between EMS and clinician, and hospital preparation for emergency patients.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)
MKJ	Automated External Defibrillators (Non-Wearable)

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: 6ea6c893-34b2-43f7-b8b8-fe51a4a37ba3
Public Version Date: September 16, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2014