AccessGUDID - DEVICE: PHILIPS HeartStart Pads Adapter for Zoll defibrillators (00884838037977)

GUDID

Device Identifier (DI) Information

Brand Name: PHILIPS HeartStart Pads Adapter for Zoll defibrillators
Version or Model: 05-10100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

Primary DI Number: 00884838037977
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079503890 *Terms of Use

Device Description: Heartstream Pads to Zoll Adapter

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):	No
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?
31683	Electrocardiographic lead switching adaptor	A switching device to which electrocardiograph (ECG) limb and chest leads may be attached. It is used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations (e.g., leads I, II and III). This device will typically be used when the devices to be connected are from different manufacturer's, enabling them to mate together. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MLN	Electrode, Electrodcardiograph, Multi-Function
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: 9e054298-abce-46af-b8b1-8f1343e320da
Public Version Date: December 07, 2020
Public Version Number: 4
DI Record Publish Date: September 24, 2014