Design Options®

Basic Information

• Brand Name: Design Options®
• Primary DI: 04046964669286
• Version / Model: 530159
• Catalog Number: 530159
• Company Name: B. BRAUN MEDICAL INC.
• Labeler DUNS: 002397347
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2020-06-16
• Public Version Status: Update
• Public Device Record Key: 03cd41f4-35b9-437c-b4e9-ee49d3afd343

Device Description

Combined Spinal/Epidural Tray

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: MR Unsafe
• 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
OFT	Spinal epidural anesthesia kit	Anesthesiology	868.5120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46308	Epidural/intrathecal anaesthesia set, non-medicated	A dual-purpose collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the intrathecal space and to the epidural space for the management of pain. It includes 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
Primary	04046964669286	GS1
Unit of Use	04046964669279	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Gauge spinal needle : 27
Device Size Text, specify			Gauge epidural needle : 17
Device Size Text, specify			Gauge (Catheter) : 19

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 1 – 40 Degrees Celsius