AccessGUDID - DEVICE: Solace™ (04046964773105)

GUDID

Device Identifier (DI) Information

Brand Name: Solace™
Version or Model: 622517
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 622517
Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC

Primary DI Number: 04046964773105
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 784259751 *Terms of Use

Device Description: 20CC-30ATM INFLATION DEVICE

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:	No
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
Catheter-balloon inflator, single-use	A sterile device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon during a medical procedure. It typically consists of a dedicated syringe/plunger mechanism, a gauge or integral pressure transducer for monitoring pressure within the balloon, a locking mechanism, and a connecting tube. It may also be used to inflate the balloon of an inflatable balloon tamp or an endomicroscopy probe. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Catheter-balloon inflator, single-use

A sterile device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon during a medical procedure. It typically consists of a dedicated syringe/plunger mechanism, a gauge or integral pressure transducer for monitoring pressure within the balloon, a locking mechanism, and a connecting tube. It may also be used to inflate the balloon of an inflatable balloon tamp or an endomicroscopy probe. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
KOE	DILATOR, URETHRAL
MAV	Syringe, balloon inflation

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: Capacity (ml) : 20.000 ML

Device Record Status

Public Device Record Key: 83163c8d-8827-42c6-81be-5ecc67f1d54a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 30, 2016