AccessGUDID - DEVICE: Design Options® (04046964315879)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 04046964315879
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: Combined Spinal/Epidural Tray

Device Characteristics

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

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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.

FDA Product Code

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Product Code	Product Code Name
OFT	Spinal epidural anesthesia kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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

Clinically Relevant Size

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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

Device Record Status

Public Device Record Key: c3596760-1bab-4201-96df-182a0ab21938
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016