AccessGUDID - DEVICE: Avance Flex Negative Pressure Wound Therapy Canister, 300ML (00860385000824)

GUDID

Device Identifier (DI) Information

Brand Name: Avance Flex Negative Pressure Wound Therapy Canister, 300ML
Version or Model: APR300
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: APRIA HEALTHCARE LLC

Primary DI Number: 00860385000824
Issuing Agency: GS1
Commercial Distribution End Date: August 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 198427874 *Terms of Use

Device Description: 300ml Avance Flex Canister for use with the Avance Flex Negative Pressure Wound Therapy Pump

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?
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 [?]
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 300 Milliliter

Device Record Status

Public Device Record Key: 7b1c385e-ff94-4522-ab8b-d525be682e3c
Public Version Date: July 19, 2021
Public Version Number: 2
DI Record Publish Date: March 23, 2018