AccessGUDID - DEVICE: Skin Prep PadAbrasive Pad for Skin Preparation (05060038515285)

GUDID

Device Identifier (DI) Information

Brand Name: Skin Prep PadAbrasive Pad for Skin Preparation
Version or Model: 2121M
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2121M
Company Name: Ambu A/S

Primary DI Number: 05060038515285
Issuing Agency: GS1
Commercial Distribution End Date: February 06, 2022
Device Count: 500
Labeler D-U-N-S® Number*: 305682023 *Terms of Use

Device Description: 2121M Skin Prep Pads - Abrasive pads Packing: 30 pouch/ 500 inner box/ 1500 carton

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 41 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6fd74e5f-f69d-4d72-bbac-d61848f8da75
Public Version Date: February 07, 2022
Public Version Number: 4
DI Record Publish Date: September 26, 2016