PCA Lockbox 100 mL

Basic Information

• Brand Name: PCA Lockbox 100 mL
• Primary DI: 17290109150021
• Version / Model: 15061-131-0004
• Catalog Number: 15061-131-0004
• 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: b112187b-24cc-4df0-aa46-8aecf37c0068

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	07290109150024	GS1
Package	27290109150028	GS1	cardboard box	12	In Commercial Distribution
Primary	17290109150021	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K123049	000

Storage Conditions

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