AccessGUDID - DEVICE: Contiplex® (04046964292460)

GUDID

Device Identifier (DI) Information

Brand Name: Contiplex®
Version or Model: 333697
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 333697
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046964292460
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: Contiplex® C Set with 30° Bevel Needle (CONTIPLEXC/30)

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:	No
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
Nerve-locating anaesthesia kit, continuous-administration	A collection of sterile devices designed to locate a peripheral nerve or nerve plexus with electrical neuromuscular stimulation, to target the percutaneous and continuous delivery of an anaesthetic for regional anaesthesia (RA). It typically includes a dedicated insulated needle or cannula with an uninsulated tip for nerve localization, an electrical cable for connection to a current generator, a catheter that may have a stimulatable stylet, a catheter inserter, and a syringe. The inserted catheter enables continuous nerve-block and localization perioperatively, and it is used to treat postoperative or chronic pain. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Nerve-locating anaesthesia kit, continuous-administration

A collection of sterile devices designed to locate a peripheral nerve or nerve plexus with electrical neuromuscular stimulation, to target the percutaneous and continuous delivery of an anaesthetic for regional anaesthesia (RA). It typically includes a dedicated insulated needle or cannula with an uninsulated tip for nerve localization, an electrical cable for connection to a current generator, a catheter that may have a stimulatable stylet, a catheter inserter, and a syringe. The inserted catheter enables continuous nerve-block and localization perioperatively, and it is used to treat postoperative or chronic pain. This is a single-use device.

FDA Product Code

[?]

Product Code	Product Code Name
CAZ	Anesthesia conduction 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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Gauge (cannula) : 25
Device Size Text, specify: Gauge (Catheter) : 19

Device Record Status

Public Device Record Key: 33b12578-f521-4cdf-be42-cff0bb536875
Public Version Date: September 21, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016