PCA Lockbox 250mL

Basic Information

• Brand Name: PCA Lockbox 250mL
• Primary DI: 17290109150076
• Version / Model: 15063-000-0001
• Catalog Number: 15063-000-0001
• Company Name: EITAN MEDICAL LTD
• Labeler DUNS: 533108028
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 4
• Public Version Date: 2022-11-23
• Public Version Status: Update
• Public Device Record Key: 817a9c00-9c4d-44e7-867b-9c45b5f00503

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
10535	Medicine cabinet	A furniture-like device designed for storing and preparing medicines. It will typically have shelves, drawers, narcotics locker, and may have other facilities, e.g., sinks or work counters. Some may even have a small built-in refrigerator.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	07290109150079	GS1
Package	27290109150073	GS1	cardboard box	3	In Commercial Distribution
Primary	17290109150076	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K141389	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius