AccessGUDID - DEVICE: WoundPro Collection Canister (10851978007037)

GUDID

Device Identifier (DI) Information

Brand Name: WoundPro Collection Canister
Version or Model: 8463540 0224
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Pensar Medical, LLC

Primary DI Number: 10851978007037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 16
Labeler D-U-N-S® Number*: 079262228 *Terms of Use

Device Description: WoundPro 800cc Collection Canister, Case of 16

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?
47404	Negative-pressure wound therapy system canister	A receptacle for the collection of excess interstitial fluid, exudate, and infectious materials from a dedicated dressing that has been applied for a vacuum-assisted wound closure procedure; commonly known as negative pressure wound therapy (NPWT). It is typically made of transparent disposable plastic materials and is connected to or placed into the NPWT system's vacuum pump. This receptacle is a single-use device that should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OMP	Negative Pressure Wound Therapy Powered Suction Pump

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150960	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dc9a3ae0-584e-41b8-ba43-0d9cf8788534
Public Version Date: October 17, 2022
Public Version Number: 1
DI Record Publish Date: October 07, 2022