AccessGUDID - DEVICE: CVS Health (00050428399286)

GUDID

Device Identifier (DI) Information

Brand Name: CVS Health
Version or Model: 894119
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Primary DI Number: 00050428399286
Issuing Agency: GS1
Commercial Distribution End Date: July 27, 2021
Device Count: 12
Labeler D-U-N-S® Number*: 062312574 *Terms of Use

Device Description: Emulsion Non-Stick Pads, all one size, 3 IN x 3 IN (76 mm x 76 mm)

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?
62732	Petrolatum non-woven gauze pad	A sterile, non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material and primarily designed to absorb fluids for medical purposes; it is impregnated with petrolatum to increase its nonadherent properties. The device is typically used to clean, cover, or pack wounds, abrasions or burns and absorb their exudates, or to absorb body-surface exudates. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ee806bd5-efb8-4745-b879-99591ebeb02a
Public Version Date: April 05, 2022
Public Version Number: 2
DI Record Publish Date: January 27, 2020