Mullins X™ 618813

GUDID 04046964316548

MULLINS-X BALLOON CATH 22X4X100 PTM453

B BRAUN INTERVENTIONAL SYSTEMS, INC

Peripheral angioplasty balloon catheter, basic
Primary Device ID04046964316548
NIH Device Record Key1f767d55-922f-40ab-a824-c67567ff4fa8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMullins X™
Version Model Number618813
Catalog Number618813
Company DUNS784259751
Company NameB BRAUN INTERVENTIONAL SYSTEMS, 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 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
GS104046964316548 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCATHETER, PERCUTANEOUS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-03-25
Device Publish Date2016-08-09

On-Brand Devices [Mullins X™]

04046964316869MULLINS-X 23X4X14X9X100X035 PTM457
04046964316845MULLINS-X 23X3X14X9X100X035 PTM456
04046964316586MULLINS-X BALLOON CATH 25X4X100 PTM455
04046964316562MULLINS-X BALLOON CATH 25X3X100 PTM454
04046964316548MULLINS-X BALLOON CATH 22X4X100 PTM453
04046964316524MULLINS-X BALLOON CATH 22X3X100 PTM452
04046964316494MULLINS-X 20X4X13X8X100X.035 PTM451
04046964316470MULLINS-X 20X3X13X8X100X.035 PTM450
04046964316456MULLINS-X 18X4X12X8X100X.035 PTM449
04046964316432MULLINS-X 18X3X12X8X100X.035 PTM448
04046964316418MULLINS-X 16X4X11X8X100X.035 PTM447
04046964316395MULLINS-X 16X3X11X8X100X.035 PTM446
04046964316357MULLINS-X 15X3X10X8X100X.035 PTM444
04046964316333MULLINS-X 14X4X10X8X100X.035 PTM443
04046964316319MULLINS-X 14X3X10X8X100X.035 PTM442
04046964316296MULLINS-X 12X4X9X7X100X.035 PTM441
04046964316272MULLINS-X 12X3X9X7X100X.035 PTM440

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