Doselogix

Basic Information

• Brand Name: Doselogix
• Primary DI: 00813360021994
• Version / Model: TCPERL01
• Catalog Number: 752645
• Company Name: TEAM TECHNOLOGIES, INC.
• Labeler DUNS: 078550672
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-30
• Public Version: 1
• Public Version Date: 2022-08-08
• Public Version Status: New
• Public Device Record Key: 69abd415-81bc-42e0-b907-2093ffe23d7f

Device Description

DOSELOGIX TCPERL01 35ML PERL VAGINAL DOSING SYSTEM

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: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HGD	Applicator, Vaginal	Obstetrics/Gynecology	884.4520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37448	Vaginal applicator, single-use	A device designed to apply medication to the vagina. It is typically a simple rod, blade, spatula, or paddle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813360021994	GS1
Package	10813360021991	GS1	Bag	25	In Commercial Distribution
Package	20813360021998	GS1	Case	10	In Commercial Distribution

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 35 – 160 Degrees Fahrenheit