AccessGUDID - DEVICE: Nuvafoam (00699923012018)

GUDID

Device Identifier (DI) Information

Brand Name: Nuvafoam
Version or Model: 3012
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3012
Company Name: Cpn Biosciences, LLC

Primary DI Number: 00699923012018
Issuing Agency: GS1
Commercial Distribution End Date: January 11, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 079896008 *Terms of Use

Device Description: Foam Dressing, 4" x 4.25"

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):	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?
44970	Exudate-absorbent dressing, non-gel, non-antimicrobial	A wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAC	Dressing, Wound, Hydrophilic

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
Special Storage Condition, Specify: Store in a dry place at room temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e2b96667-4422-4bc6-a6a4-ca18640cfdbb
Public Version Date: January 26, 2024
Public Version Number: 2
DI Record Publish Date: September 22, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00699923012100	10	00699923012018	2024-01-11	Not in Commercial Distribution	Box of 10 pouches
00699923012506	12	00699923012100	2024-01-11	Not in Commercial Distribution	Case of 12 boxes