N/A

Basic Information

• Brand Name: N/A
• Primary DI: 10885403143243
• Version / Model: 4540A
• Catalog Number: 4540A
• Company Name: CAREFUSION 2200, INC
• Labeler DUNS: 832696038
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2023-08-01
• Public Version Status: Update
• Public Device Record Key: bdb431e4-5a0b-4028-af4c-6a0c53ba686f
• Distribution End Date: 2027-12-23

Device Description

Paracervical/Pudendal Block Tray - 10 ml Control 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: Yes
• Not Made with NRL: No
• 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: Yes
• 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
HEE	SET, ANESTHESIA, PARACERVICAL	Obstetrics/Gynecology	884.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46382	Peripheral anaesthesia single-administration set, non-medicated	A collection of devices intended for the single-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block; it is not dedicated to dental use. It includes an anaesthesia needle and a syringe often with additional devices utilized for the procedure (e.g., dressings); as a single-administration set it does not include a catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885403143241	GS1	Case	20	In Commercial Distribution	2027-12-23
Primary	10885403143243	GS1

Customer Contacts

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