AccessGUDID - DEVICE: Renasys (00040565127293)

GUDID

Device Identifier (DI) Information

Brand Name: Renasys
Version or Model: 66021811
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 66021811
Company Name: SMITH & NEPHEW MEDICAL LIMITED

Primary DI Number: 00040565127293
Issuing Agency: GS1
Commercial Distribution End Date: February 19, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 216344051 *Terms of Use

Device Description: Renasys EZ Max Quick Reference Guide US

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:	No
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 [?]
K142979	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: c5751456-6c97-4d4b-b580-7a033788aa3f
Public Version Date: February 20, 2024
Public Version Number: 6
DI Record Publish Date: September 23, 2016