AccessGUDID - DEVICE: ASP MEDICAL (00840216108639)

GUDID

Device Identifier (DI) Information

Brand Name: ASP MEDICAL
Version or Model: PPA020
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Asp Global, LLC

Primary DI Number: 00840216108639
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080361159 *Terms of Use

Device Description: PAD, ALCOHOL PREP, STERILE, MEDIUM, NON-WOVEN, SIZE 30X60MM, 200EA/BX, 20BX/CS (4000EA/CS)

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKB	Pad, Alcohol, Device Disinfectant

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: Yes

Sterilization Method [?]
Radiation Sterilization

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: 471be500-7c44-46b9-b38c-6dd4e046a01d
Public Version Date: September 08, 2022
Public Version Number: 1
DI Record Publish Date: August 31, 2022