NIO NEXT GENERATION IO

Basic Information

• Brand Name: NIO NEXT GENERATION IO
• Primary DI: 00850026832105
• Version / Model: 1
• Company Name: EINSTEIN WORKS, LLC
• Labeler DUNS: 098121274
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-03
• Public Version: 2
• Public Version Date: 2022-02-21
• Public Version Status: Update
• Public Device Record Key: 9a8916bc-cd49-4c80-bc7a-3688efaaf097

Device Description

NIO FIXATION DRESSING

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KMK	Device, Intravascular Catheter Securement	General Hospital	880.5210	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47011	First aid absorbent pad/bandage	A wound cover intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding, and introduce medications placed on the pad. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850026832102	GS1	BOX	12	In Commercial Distribution
Primary	00850026832105	GS1