Busse Hospital Disposables

Basic Information

• Brand Name: Busse Hospital Disposables
• Primary DI: 00849233013360
• Version / Model: 682
• Catalog Number: 682
• Company Name: ROBERT BUSSE & CO., INC.
• Labeler DUNS: 002418234
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-02
• Public Version: 5
• Public Version Date: 2020-03-26
• Public Version Status: Update
• Public Device Record Key: 66f284a3-ff93-4790-92b1-ef61795a2fc1

Device Description

Single shot Epidural Tray with 18 Gauge x 3 1/2" Tuohy Needle and LOR L/S Syringe

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OGJ	Nerve Block Tray	Anesthesiology	868.5140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34842	Epidural anaesthesia set, non-medicated	A collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849233013360	GS1
Package	10849233013367	GS1		10	In Commercial Distribution

Customer Contacts

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