Archimedes Dilation Balloon 10008

GUDID 00856571007074

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.

BRONCUS MEDICAL INC.

Bronchial balloon catheter
Primary Device ID00856571007074
NIH Device Record Key1357f10b-a7e8-4c9f-a270-bedd2c841ce6
Commercial Distribution StatusIn Commercial Distribution
Brand NameArchimedes Dilation Balloon
Version Model Number10008
Catalog Number10008
Company DUNS078684808
Company NameBRONCUS MEDICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone650-428-1600
EmailCustomerSupport@Broncus.com

Device Dimensions

Outer Diameter1.9 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100856571007074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOQBronchoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-22
Device Publish Date2017-06-27

Devices Manufactured by BRONCUS MEDICAL INC.

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