AccessGUDID - DEVICE: HeartStart (00884838003316)

GUDID

Device Identifier (DI) Information

Brand Name: HeartStart
Version or Model: Switched Int Pdl Adapter
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: M4740A
Company Name: Philips Medical Systems Hsg

Primary DI Number: 00884838003316
Issuing Agency: GS1
Commercial Distribution End Date: May 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 790605856 *Terms of Use

Device Description: HS Switchless Int Pdl 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):	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?
35041	Electrosurgical cable adaptor	A small connector used to join the cable(s) from a handpiece/electrode(s) (active and/or return) to the generator of an electrosurgical system. This device will typically be used when the system components are from different manufacturers and the connections are not compatible. This is a reusable device.	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
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Temperature: between -4 and 158 Degrees Fahrenheit
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 58a5b89e-39f5-4948-9c6a-b5bf7e03aa71
Public Version Date: March 15, 2024
Public Version Number: 4
DI Record Publish Date: January 31, 2021