AccessGUDID - DEVICE: Design Options® (04046964315879)

GUDID

Brand Name: Design Options®
Version or Model: 555482
Catalog Number: 555482
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046964315879
Issuing Agency: GS1
Device Count: 10

Device Description: Combined Spinal/Epidural Tray

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Epidural/intrathecal anaesthesia kit	A collection of sterile devices designed to deliver an analgesic or anaesthetic agent into the epidural and subarachnoid (intrathecal) spaces around the spinal cord for pain management. It typically includes a procedural needle(s), syringe, catheter(s), and filter(s), but does not include medication. This is a single-use device.

Product Code	Product Code Name
OFT	Spinal epidural anesthesia kit

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling
Storage Environment Temperature: between 20 and 25 Degrees Celsius
Handling Environment Temperature: between 1 and 40 Degrees Celsius

Size Type Text
Device Size Text, specify: Gauge epidural needle : 17
Device Size Text, specify: Gauge (Catheter) : 19
Device Size Text, specify: Gauge spinal needle : 25

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 23, 2016
Commercial Distribution End Date:

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI Number: 04046964315855 CLOSE

Device Subject to Direct Marking (DM), but Exempt: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Phone: +1(800)227-2862
Email: BBMUS_Service.EmailOrders@bbraun.com