AccessGUDID - DEVICE: NA (00884838014732)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 452230032261
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 452230032261
Company Name: Philips Ds North America LLC

Primary DI Number: 00884838014732
Issuing Agency: GS1
Commercial Distribution End Date: December 15, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 013649151 *Terms of Use

Device Description: No description.

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?
36038	Radiolucent electrocardiographic lead	A radiolucent insulated metal or non-metallic wire(s) with an electrode used to conduct electrical signals from a patient's heart, via the electrode which is attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine. It is typically used during cardiac catheterization procedures because it will cast a slight or negligible shadow on the radiographic images. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MWI	Monitor, physiological, patient (without arrhythmia detection or alarms)

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: e11e257f-a38e-42d2-9d6d-d759a273fce6
Public Version Date: February 01, 2024
Public Version Number: 3
DI Record Publish Date: June 26, 2018