Safe Rx

Basic Information

• Brand Name: Safe Rx
• Primary DI: 00852035008250
• Version / Model: 60 dram cap and ring blue 50 pack
• Company Name: Safe-Rx LLC
• Labeler DUNS: 080632475
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2024-02-06
• Public Version: 2
• Public Version Date: 2024-02-15
• Public Version Status: Update
• Public Device Record Key: a7f38994-95f5-4a20-9623-d895c5338758

Device Description

The 60 dram dispensing kits (the 50 packs that will be sold to the pharmacies) (GTIN:00852035008250)will be composed of: 2 encoders, 60 dram (GTIN: 00852035008212) 50 large pharmacy patient vials (GTIN: 00852035008236), each of which are composed of: i. LPV – 60 dram Blue (GTIN: 00852035008175) ii. 60-dram cap and ring set (GTIN: 00852035008021)

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
16617	Medicine bottle cap	A sturdy covering designed to close off and seal the top of a medicine bottle providing protection from the external environment. It will typically consist of a plastic cover that may include a glued or cemented liner/seal, e.g., rubber or plastic. Some devices are threaded for screwing on to the bottle. Medicine bottle caps are frequently made with a built-in safety feature locking mechanism making them child proof, e.g., require a push-down/screw action to open. This device is reusable until the contents of the bottle are exhausted.	No	Active
16616	Medicine bottle	An empty glass or plastic container, typically with a relatively narrow neck and a lid/cap, intended to be used to store medication so that it retains its viability. This is typically a single-patient device that is reused until the contents are exhausted.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00852035008236	GS1
Primary	00852035008250	GS1