AccessGUDID - DEVICE: Ambu WhiteSensor (08906035283406)

GUDID

Device Identifier (DI) Information

Brand Name: Ambu WhiteSensor
Version or Model: 2121M
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDICO ELECTRODES INTERNATIONAL LIMITED

Primary DI Number: 08906035283406
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 677425215 *Terms of Use

Device Description: Electrode skin abrasion pad

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":	Yes
For Single-Use:	Yes
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?
47102	Electrode skin abrasion pad	A small, abrasive, hand-held device intended to be rubbed over select skin surface areas of a patient in preparation for placement of electrocardiograph (ECG) electrodes. It is used to remove superficial skin cells to enhance electrical contact (conductivity) for optimal ECG signals. It is typically used by emergency medical services (EMS). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRX	Electrode, Electrocardiograph

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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 5 and 30 Degrees Celsius
Storage Environment Temperature: between 41 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ec2c7b80-b9c8-4c04-88aa-ef0709474124
Public Version Date: August 28, 2020
Public Version Number: 1
DI Record Publish Date: August 20, 2020