AccessGUDID - DEVICE: NIKOPrep (10853512006773)

GUDID

Device Identifier (DI) Information

Brand Name: NIKOPrep
Version or Model: 2121/E 240
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2121/E 240
Company Name: NIKOMED USA

Primary DI Number: 10853512006773
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 073648341 *Terms of Use

Device Description: Strips for Skin Preparation (Individual Pieces)

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:	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c3a4fd37-722c-4375-a4d3-b7cb3b6fab04
Public Version Date: October 27, 2022
Public Version Number: 1
DI Record Publish Date: October 19, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00853512006776 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)355-6456
Email: info@nikomedusa.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES