AccessGUDID - DEVICE: CVS Health® (00050428539828)

GUDID

Device Identifier (DI) Information

Brand Name: CVS Health®
Version or Model: 716597
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 716597
Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Primary DI Number: 00050428539828
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 062312574 *Terms of Use

Device Description: Manuka Honey Wound Gel

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
47773	Medical honey liquid barrier dressing	A material formed from medical grade honey intended to protect wounds or tissue surfaces by providing a non-occlusive external barrier to bacteria and the environment. It also helps to maintain a moist internal environment for wounds to assist the healing process. The material may be liquid or semi-liquid and is typically applied directly to the wound or tissue surface (e.g., ocular surface). 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: No
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: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 0.5 OZ
Weight: 14 Gram

Device Record Status

Public Device Record Key: 6d97b7f5-5796-40b3-87ef-8379bd515fef
Public Version Date: November 07, 2022
Public Version Number: 2
DI Record Publish Date: September 24, 2022