AccessGUDID - DEVICE: ExuCare HD Large (00850051939022)

GUDID

Device Identifier (DI) Information

Brand Name: ExuCare HD Large
Version or Model: EC5350-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ECHD300
Company Name: SUN SCIENTIFIC, INC.

Primary DI Number: 00850051939022
Issuing Agency: GS1
Commercial Distribution End Date: May 18, 2030
Device Count: 1
Labeler D-U-N-S® Number*: 609397224 *Terms of Use

Device Description: A wound cover that wraps around the leg which is intended to be used as an initial, short-term treatment after injury that consists of an high drainage absorbent pad (e.g., gauze, cotton wool, lint, cellulose) The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding. This is a single-use device.

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):	Yes
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?
47011	First aid absorbent pad/bandage	A wound cover intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding, and introduce medications placed on the pad. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAC	Dressing, Wound, Hydrophilic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: f6a57d35-e602-4da3-9d30-a2a0b9958159
Public Version Date: April 19, 2023
Public Version Number: 1
DI Record Publish Date: April 11, 2023