Voluminous™ 622513

GUDID 04046964539022

40CC-15ATM VOLUMINOUS INFLATION DEVICE

B BRAUN INTERVENTIONAL SYSTEMS, INC

Catheter-balloon inflator, single-use
Primary Device ID04046964539022
NIH Device Record Key86c06ca6-9c60-45cf-9333-26d5e17e4323
Commercial Distribution StatusIn Commercial Distribution
Brand NameVoluminous™
Version Model Number622513
Catalog Number622513
Company DUNS784259751
Company NameB BRAUN INTERVENTIONAL SYSTEMS, INC
Device Count10
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)836-2228
Email[email protected]

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT

Device Identifiers

Device Issuing AgencyDevice ID
GS104046964318375 [Unit of Use]
GS104046964539022 [Primary]

FDA Product Code

MAVSyringe, balloon inflation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-25
Device Publish Date2016-08-09

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