AccessGUDID - DEVICE: Family Wellness (00032251058141)

GUDID

Device Identifier (DI) Information

Brand Name: Family Wellness
Version or Model: 032251058141
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0910862
Company Name: Family Dollar Stores

Primary DI Number: 00032251058141
Issuing Agency: GS1
Commercial Distribution End Date: January 07, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 117310689 *Terms of Use

Device Description: Waterproof Adhesive Tape, 1/2 IN x 5 YDS (12.7 mm x 4.5 m)

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):	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?
34832	Waterproof skin adhesive tape	A long and narrow flexible band that is coated on one side with a pressure-sensitive adhesive, and made from a material designed to resist water permeation, intended to be used to cover a surface (e.g., small wound), fix a dressing, attach objects, and/or exert pressure on a body part; it is not hypoallergenic. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape And Bandage, Adhesive

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: 6a55e72d-271f-44f1-ab11-4fa3874ade84
Public Version Date: August 23, 2021
Public Version Number: 3
DI Record Publish Date: February 28, 2020