BD Combined Spinal Epidural Tray

Basic Information

• Brand Name: BD Combined Spinal Epidural Tray
• Primary DI: 50382904008319
• Version / Model: 400831
• Catalog Number: 400831
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 001292192
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-09-02
• Public Version: 1
• Public Version Date: 2023-09-11
• Public Version Status: New
• Public Device Record Key: 66e90773-cf6f-42a0-96e9-031deddf9410

Device Description

27GX4 11/16IN WHIT,18GX3.5IN WEISS,CE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
CAZ	Anesthesia conduction kit	Anesthesiology	868.5140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64348	Epidural/intrathecal anaesthesia set, medicated	A dual-purpose collection of devices intended for the administration of an analgesic or anaesthetic agent to the intrathecal space and to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent, and both a spinal needle and an epidural needle with additional devices utilized for the procedure (e.g., dressings, syringe), and may include an epidural catheter for continuous-administration. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00382904008314	GS1
Primary	50382904008319	GS1

Storage Conditions

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