AccessGUDID - DEVICE: Renasys Touch (05000223490782)

GUDID

Device Identifier (DI) Information

Brand Name: Renasys Touch
Version or Model: 66801791
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 66801791
Company Name: SMITH & NEPHEW MEDICAL LIMITED

Primary DI Number: 05000223490782
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 216344051 *Terms of Use

Device Description: RENASYS TOUCH CONNECT Pump provides negative pressure therapy to a wound at a range of pressure settings via a tube set connected to a wound dressing. Pressure setting deliver setup is selectable via LCD screen. The suction pump creates negative pressure and removes exudate from the wound site to a disposable canister. The device can operate by either an external mains power supply or internal battery. The RENASYS TOUCH CONNECT pump has the facility to connect wirelessly to a cloud based system. Several accessories are available for use with the Pump including Canisters, Power supply either Class I or II, Carry Bag, Carry Strap and IV Pole/Bed Clamp. The Pump is suitable for use in both hospital and homecare settings. The Pump is compatible with existing Smith & Nephew Negative Pressure wound dressing kits on the market.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
47955	Negative-pressure wound therapy system, battery-powered, reusable	A portable assembly of devices designed to treat hard-to-heal open wounds (e.g., traumatic and chronic) and diabetic/pressure ulcers with suction. It typically consists of a non-sterile battery-powered vacuum pump, an integrated disposable collection canister, and a shoulder bag for carrying during ambulation. It is connected to the patient with drainage tubing. The pump applies continuous or intermittent negative pressure to the wound via the tube/dressing to decompress capillaries/lymphatic vessels, improve blood/interstitial fluid circulation, draw wound edges together, facilitate granulation tissue formation, and prepare the wound bed for closure. This is a reusable device.	Obsolete	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 [?]
K181822	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: 327cf6ee-13d9-4342-8ed8-f976ba56021e
Public Version Date: September 07, 2023
Public Version Number: 3
DI Record Publish Date: June 24, 2019