AccessGUDID - DEVICE: Archimedes Dilation Balloon (00856571007074)

GUDID

Device Identifier (DI) Information

Brand Name: Archimedes Dilation Balloon
Version or Model: 10008
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10008
Company Name: BRONCUS MEDICAL INC.

Primary DI Number: 00856571007074
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078684808 *Terms of Use

Device Description: A sterile single use flexible tube with a balloon at or near the distal tip that is inserted through the bronchoscope or sheath and used to dilate the target lung tissue of the bronchial tree.

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":	No
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17827	Bronchial balloon catheter	A sterile flexible tube designed with a balloon at or near the distal tip that may be introduced directly (usually under fluoroscopic guidance) or through a bronchoscope so that its distal tip reaches the bronchi, permitting the inflation of the balloon after introduction. The device is typically used to treat benign stenosis and strictures of the airway and/or to control pulmonary bleeding (i.e., hemoptysis). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EOQ	Bronchoscope (Flexible Or Rigid)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131234	000

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
Special Storage Condition, Specify: Room Temperature

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 1.9 Millimeter

Device Record Status

Public Device Record Key: 1357f10b-a7e8-4c9f-a270-bedd2c841ce6
Public Version Date: February 22, 2019
Public Version Number: 4
DI Record Publish Date: June 27, 2017