N/A

Basic Information

• Brand Name: N/A
• Primary DI: 10885403057052
• Version / Model: 4304C
• Catalog Number: 4304C
• Company Name: CAREFUSION 2200, INC
• Labeler DUNS: 832696038
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2024-01-01
• Public Version Status: Update
• Public Device Record Key: 0121daee-bd77-4c4b-bbfc-92621fae887d
• Distribution End Date: 2023-12-30

Device Description

Pediatric/Infant Lumbar Puncture Tray - 21 G x 2 1/2 Inch Spinal Needle with Manometer

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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
PWY	Lumbar puncture tray (adult & pediatric)	General Hospital	880.5570	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
Package	50885403057050	GS1	Case	10	Not in Commercial Distribution	2023-12-30
Primary	10885403057052	GS1

Customer Contacts

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

Storage Conditions

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