AccessGUDID - DEVICE: Comfort Shield Adult Underpads (00891237001539)

GUDID

Device Identifier (DI) Information

Brand Name: Comfort Shield Adult Underpads
Version or Model: 1539
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HOME AIDE DIAGNOSTICS, INC.

Primary DI Number: 00891237001539
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 783518983 *Terms of Use

Device Description: • 150 underpads per box • Size: 30in x 36in • 28" wide pad • 60 grams of padding • 24" of padded protection • Extra absorbent underpads for incontinence • Provides excellent protection for beds and chairs • Absorbs well to prevent leakage • Reduces odors and maintains dryness

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):	No
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?
33961	General surgical procedure kit, non-medicated, single-use	A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KME	Bedding, Disposable, Medical

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: 44e86b80-ff45-4874-b48b-200c96c7ec97
Public Version Date: June 17, 2022
Public Version Number: 3
DI Record Publish Date: July 18, 2018