PCA Lockbox 250 Strap and Pouch

Basic Information

• Brand Name: PCA Lockbox 250 Strap and Pouch
• Primary DI: 17290109151653
• Version / Model: 15063-000-0004
• Company Name: EITAN MEDICAL LTD
• Labeler DUNS: 533108028
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-19
• Public Version: 1
• Public Version Date: 2024-03-27
• Public Version Status: New
• Public Device Record Key: f018b30c-02e3-48be-be30-488fe8415bc7

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
MRZ	Accessories, Pump, Infusion	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34886	Narcotics security storage cabinet	A furniture-like device specially designed to provide a secure storage for narcotics. It can have double walls, two locks with separate keys, reinforced hinges, and other security design measures to prevent illegal entrance. Such cabinets will typically be installed in hospital wards or institutions.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	27290109151650	GS1		24	In Commercial Distribution
Primary	17290109151653	GS1

Premarket Submissions

Submission Number	Supplement Number
K192860	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 40 – 70 Degrees Celsius