AccessGUDID - DEVICE: Design Options® (04046955114351)

GUDID

Device Identifier (DI) Information

Brand Name: Design Options®
Version or Model: 570292
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 570292
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046955114351
Issuing Agency: GS1
Commercial Distribution End Date: December 21, 2021
Device Count: 10
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: BPSK YALE NEW HAVEN/ST. RAPHAEL

Device Characteristics

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64347	Peripheral anaesthesia catheter set, medicated	A collection of devices intended for the continuous-administration of an anaesthetic agent to function as a peripheral nerve-block. It includes a pharmaceutical anaesthetic agent, an anaesthesia catheter, and an anaesthesia needle usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OGJ	Nerve block tray

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

[?]

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

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: d833cfb0-a3ec-4723-a8a3-52886b36f228
Public Version Date: December 27, 2021
Public Version Number: 5
DI Record Publish Date: October 12, 2017