AccessGUDID - DEVICE: Design Options® (04046964317910)

GUDID

Brand Name: Design Options®
Version or Model: 560123
Catalog Number: 560123
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046964317910
Issuing Agency: GS1
Device Count: 10

Device Description: Spinal Tray

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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
Intrathecal anaesthesia kit	A collection of sterile devices and supplies used to deliver an analgesic or anaesthetic agent to the subarachnoid (intrathecal) space around the spinal cord. It is used for pain management and typically consists of a procedural needle, syringe, catheter, and a filter, but does not include medication. This is a single-use device.

Product Code	Product Code Name
OFU	Spinal 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

Size Type Text
Device Size Text, specify: Gauge spinal needle : 24

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: 04046964317897 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