AccessGUDID - DEVICE: Design Options® (04046964306815)

GUDID

Brand Name: Design Options®
Version or Model: 551411
Catalog Number: 551411
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046964306815
Issuing Agency: GS1
Device Count: 10

Device Description: Continuous Epidural 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
Epidural anaesthesia kit, medicated	A collection of sterile devices, including a pharmaceutical(s), intended to be used to deliver an analgesic or anaesthetic agent to the epidural space for pain management. It typically consists of a procedural needle, a syringe, an analgesic/anaesthetic agent, and typically includes dressings, drapes, towels, or swabs. This is a single-use device.

Product Code	Product Code Name
OGE	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

Size Type Text
Device Size Text, specify: Gauge (Catheter) : 20
Device Size Text, specify: Gauge epidural needle : 18

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: 04046964306808 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