H-E-B

Basic Information

• Brand Name: H-E-B
• Primary DI: 00041220728138
• Version / Model: 041220728138
• Company Name: H. E. BUTT GROCERY COMPANY
• Labeler DUNS: 007924756
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2019-08-30
• Public Version: 3
• Public Version Date: 2020-08-07
• Public Version Status: Update
• Public Device Record Key: 46221025-ae27-44f9-8f1e-229327f23cb6

Device Description

Watershield Adhesive Pads, all one size, 3 IN x 4 IN

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34864	Adhesive bandage	A sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.	No	Active
44990	Skin-cover adhesive strip, non-antimicrobial	A small, narrow, flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive and possibly with an absorbent pad, typically intended to cover a superficial wound or fix a dressing to skin. It may be hypoallergenic and/or waterproof, however it does not include antimicrobial agents/properties. Commonly referred to as a sticking plaster, it is intended for use in the home or a clinical setting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20041220728132	GS1	case	72	In Commercial Distribution
Primary	00041220728138	GS1
Unit of Use	60041220728130	GS1