AccessGUDID - DEVICE: POWERWAND (10859821006374)

GUDID

Device Identifier (DI) Information

Brand Name: POWERWAND
Version or Model: Dressing Change Kit with StatLock
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71697
Company Name: ACCESS SCIENTIFIC, LLC

Primary DI Number: 10859821006374
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079290879 *Terms of Use

Device Description: POWERWAND Dressing Change Kit with StatLock

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:	Yes
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?
56631	Wearable percutaneous catheter/tube holder	A device designed to fix a percutaneous catheter, tube, and/or drain (e.g., IV, epidural, or drainage catheter, GI tube) to a patient's body without suturing; it may additionally be intended for holding a non-surgically-invasive tube (e.g., nasogastric tube) to the patient (universal holder). It is designed as an adhesive pad, strip, or bandage that will attach to the patient's skin, sometimes with the exposed side having an integrated fixation mechanism (e.g., Velcro hook/loop closure) or a mechanical closure, to hold the catheter/tube in place. It may include a transparent film portion intended for fixation site monitoring. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OXQ	Dressing Change Tray

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 32 and 104 Degrees Fahrenheit
Special Storage Condition, Specify: Protect from direct contact with sun, water and humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6ba743ef-d3b2-4f35-b153-4b99dca2d9ae
Public Version Date: July 22, 2019
Public Version Number: 5
DI Record Publish Date: September 09, 2016