Busse Hospital Disposables

Basic Information

• Brand Name: Busse Hospital Disposables
• Primary DI: 00849233013193
• Version / Model: 645
• Catalog Number: 645
• Company Name: ROBERT BUSSE & CO., INC.
• Labeler DUNS: 002418234
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 46cb0cd6-c027-4cda-8185-155c997d5e17

Device Description

Pediatric/Infant Lumbar Puncture Tray/ w/ 21 G x 2.5" spinal needle & monometer

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: No
• 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
FMJ	Manometer, Spinal-Fluid	General Hospital	880.2500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12404	Lumbar puncture kit	A collection of sterile devices designed to perform a puncture of the lumbar spine to obtain spinal fluid. Typical components include a spinal needle and collection tubes for spinal fluid. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849233013193	GS1
Package	10849233013190	GS1		10	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius