AccessGUDID - DEVICE: RENASYS EDGE (05000223501075)

GUDID

Device Identifier (DI) Information

Brand Name: RENASYS EDGE
Version or Model: 66803140
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 66803140
Company Name: SMITH & NEPHEW MEDICAL LIMITED

Primary DI Number: 05000223501075
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 216344051 *Terms of Use

Device Description: 800ml EDGE Canister with Solidifier

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?
20395	Negative-pressure wound therapy system, electric, reusable	An assembly of devices designed to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps, and grafts with suction. It typically consists of a dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, an evacuation tube, a collection canister, and an electrically-powered vacuum pump. The pump applies continuous or intermittent negative pressure to the wound via the tube to the dressing which decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. This is a reusable device.	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 [?]
K223041	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
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 800 Milliliter

Device Record Status

Public Device Record Key: 2a90da86-ab96-4a15-9a27-1902db63f1d0
Public Version Date: September 07, 2023
Public Version Number: 2
DI Record Publish Date: April 26, 2023