AquaGuard

Basic Information

• Brand Name: AquaGuard
• Primary DI: 00618125190348
• Version / Model: 50010-RBX
• Catalog Number: 50010-RBX
• Company Name: TIDI PRODUCTS, LLC
• Labeler DUNS: 063519193
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2023-08-03
• Public Version: 1
• Public Version Date: 2023-08-11
• Public Version Status: New
• Public Device Record Key: 23274962-ffe0-4e36-813f-11caa7504b2c

Device Description

TIDI Moisture Barrier Clear Polyethylene 50 per Box

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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
33536	Cast/bandage waterproof bathing cover, single-use	A device made of waterproof materials designed to be placed over a treated area of the body, typically a plaster cast, stitches, bandage, dressing, or PICC line, to keep the area dry while the user is having a shower or a bath. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10618125190345	GS1	Case	10	In Commercial Distribution
Primary	00618125190348	GS1
Unit of Use	80618125190344	GS1