AccessGUDID - DEVICE: Procellera Single Layer (00810198030310)

GUDID

Device Identifier (DI) Information

Brand Name: Procellera Single Layer
Version or Model: 12" x 12"
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VSR-1212
Company Name: Vomaris Wound Care, Inc.

Primary DI Number: 00810198030310
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080126901 *Terms of Use

Device Description: Procellera Single Layer Rx 12" x 12"

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):	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?
59943	Portable pneumatic high-frequency ventilator	A pneumatically-powered device designed to be easily moved/mounted and intended to provide long-term support or therapeutic alveolar ventilation for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs using a frequency that is considerably higher than physiological breathing rates and a tidal volume less than or equal to the anatomic dead space (percussive ventilation), typically through an endotracheal (ET) tube, tracheostomy cannula, or mask. It typically includes a control system and alarms, sometimes with additional features (e.g., humidification).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160783	000

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: 76f21b58-87e0-47b7-a8e2-266b7e023a97
Public Version Date: November 28, 2022
Public Version Number: 1
DI Record Publish Date: November 18, 2022