Z-MED II™ 611745

GUDID 04046964337253

PDZ645 ZMED II 15X4X100

B BRAUN INTERVENTIONAL SYSTEMS, INC

Cardiac valvuloplasty catheter
Primary Device ID04046964337253
NIH Device Record Key1a6f593d-2059-4ddb-8701-294b7f6ad4c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameZ-MED II™
Version Model Number611745
Catalog Number611745
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
GS104046964337253 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OZTBalloon aortic valvuloplasty

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

On-Brand Devices [Z-MED II™]

04046964338342SO045 SPECIAL ZMED II 25X3X120
04046964338328SO044 SPECIAL ZMED II 23X3X120
04046964338281SO042 SPECIAL ZMED II 25X2X85
04046964338243SO040 SPECIAL ZMED II 25X2X100
04046964338229SO039 SPECIAL ZMED II 11X4X100
04046964338007SO028 SPECIAL ZMED II 11X3X100
04046964337772PDZ671 SPECIAL ZMED II 25X6X100
04046964337758PDZ670 ZMED II 25X5X100
04046964337734PDZ669 ZMED II 25X4X100
04046964337710PDZ668 SPECIAL ZMED II 25X3X100
04046964337697PDZ667 SPECIAL ZMED II 23X6X100
04046964337673PDZ666 SPECIAL ZMED II 23X5X100
04046964337659PDZ665 ZMED II 23X4X100
04046964337635PDZ664 SPECIAL ZMED II 23X3X100
04046964337611PDZ663 SPECIAL ZMED II 22X6X100
04046964337598PDZ662 SPECIAL ZMED II 22X5X100
04046964337574PDZ661 ZMED II 22X4X100
04046964337543PDZ659 SPECIAL ZMED II 20X6X100
04046964337529PDZ658 SPECIAL ZMED II 20X5X100
04046964337499PDZ657 ZMED II 20X4X100
04046964337475PDZ656 SPECIAL ZMED II 20X3X100
04046964337451PDZ655 ZMED II 18X6X100
04046964337437PDZ654 SPECIAL ZMED II 18X5X100
04046964337413PDZ653 ZMED II 18X4X100
04046964337390PDZ652 ZMED II 18X3X100
04046964337376PDZ651 ZMED II 16X6X100
04046964337352PDZ650 SPECIAL ZMED II 16X5X100
04046964337338PDZ649 ZMED II 16X4X100
04046964337314PDZ648 ZMED II 16X3X100
04046964337291PDZ647 SPECIAL ZMED II 15X6X100
04046964337277PDZ646 SPECIAL ZMED II 15X5X100
04046964337253PDZ645 ZMED II 15X4X100
04046964337239PDZ644 ZMED II 15X3X100
04046964337215PDZ643 SPECIAL ZMED II 14X6X100
04046964337192PDZ642 SPECIAL ZMED II 14X5X100
04046964337178PDZ641 ZMED II 14X4X100
04046964337154PDZ640 ZMED II 14X3X100
04046964337130PDZ639 SPECIAL ZMED II 12X6X100
04046964337116PDZ638 SPECIAL ZMED II 12X5X100
04046964337093PDZ637 ZMED II 12X4X100
04046964337079PDZ636 ZMED II 12X3X100
04046964337062PDZ635 ZMED II 12X2X100
04046964337048PDZ634 SPECIAL ZMED II 10X6X100
04046964337024PDZ633 SPECIAL ZMED II 10X5X100
04046964337000PDZ632 ZMED II 10X4X100
04046964336997PDZ631 ZMED II 10X3X100
04046964336966PDZ630 ZMED II 10X2X100
04046964336942PDZ629 SPECIAL ZMED II 9X6X100
04046964336928PDZ628 SPECIAL ZMED II 9X5X100
04046964336911PDZ627 SPECIAL ZMED II 9X4X100

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