AccessGUDID - DEVICE: CVS Health® (00050428513620)

GUDID

Device Identifier (DI) Information

Brand Name: CVS Health®
Version or Model: 311311
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 311311
Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Primary DI Number: 00050428513620
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 062312574 *Terms of Use

Device Description: Antimicrobial* Silver Alginate Dressings

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?
47474	Exudate-absorbent dressing, hydrophilic-gel, antimicrobial	A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.	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
Storage Environment Temperature: between 10 and 25 Degrees Celsius
Storage Environment Temperature: between 50 and 77 Degrees Fahrenheit
Special Storage Condition, Specify: Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry

Clinically Relevant Size

[?]

Size Type Text
Length: 2 Inch
Width: 2 Inch
Device Size Text, specify: 5.1 cm x 5.1 cm

Device Record Status

Public Device Record Key: bcdf048d-9e26-47d4-915f-02668414a829
Public Version Date: October 03, 2022
Public Version Number: 1
DI Record Publish Date: September 24, 2022