ADDTO

Basic Information

• Brand Name: ADDTO
• Primary DI: 00860001236019
• Version / Model: 2221
• Catalog Number: 2221
• Company Name: Addto
• Labeler DUNS: 076860139
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-15
• Public Version: 2
• Public Version Date: 2020-12-04
• Public Version Status: Update
• Public Device Record Key: 98a04550-2651-4ffc-a7fd-a1050e8b92fa

Device Description

Catheter Plug And Tube Tip Protector

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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
GCE	Adaptor, Catheter	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61355	Urethral catheterization support kit, urinary drainage	A collection of non-surgically invasive devices intended to assist a healthcare professional to insert a urethral catheter (not included) into the urinary bladder, typically for drainage of urine; some types may also be intended for catheter removal. It typically includes forceps, dressings, gloves, and drapes; it does not include pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860001236019	GS1
Package	00860001236040	GS1	Box	100	In Commercial Distribution
Package	00860001236057	GS1	Case	8	In Commercial Distribution