AccessGUDID - DEVICE: ONE-CARE Alcohol Prep Pads (00810008211700)

GUDID

Device Identifier (DI) Information

Brand Name: ONE-CARE Alcohol Prep Pads
Version or Model: ONE-CARE Alcohol Prep Pads, 70%, M, Box of 200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1022
Company Name: MediVena, LLC

Primary DI Number: 00810008211700
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080740980 *Terms of Use

Device Description: ONE-CARE Alcohol Prep Pads are saturated with 70% Isopropyl Alcohol for optimal antiseptic action. They are intended for topical use in preparation of skin prior to an injection or blood collection, cleaning of minor cuts and scrapes, or cleaning of medical equipment and supplies. Reliable 4-layer packaging provides air-tight seal and prevents leakage or dry-out.

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):	No
Over the Counter (OTC):	Yes
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?
61695	Skin-cleaning wipe, sterile	A sterile device consisting of an absorbent fabric pre-soaked in a liquid solution (e.g. a detergent, alcohol, saline) intended for cleaning a localized body surface before a procedure or device application, and/or to maintain skin hygiene. It is commonly known as a wet wipe and is intended for use in the home or healthcare facility. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LRJ	Disinfectant, Medical Devices

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 32 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a10d5408-33b1-4f67-8bd4-41867bf2b35f
Public Version Date: October 26, 2023
Public Version Number: 1
DI Record Publish Date: October 18, 2023