D'VILL™ 612845

GUDID 04046955128297

DV1485 DVill Intro 14F 85cm 0.035GW

B BRAUN INTERVENTIONAL SYSTEMS, INC

Vascular catheter introduction set, nonimplantable
Primary Device ID04046955128297
NIH Device Record Key3a0f6b22-7429-48c6-b622-fad991f33de3
Commercial Distribution StatusIn Commercial Distribution
Brand NameD'VILL™
Version Model Number612845
Catalog Number612845
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
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT

Device Identifiers

Device Issuing AgencyDevice ID
GS104046955128297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBINTRODUCER, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-25
Device Publish Date2018-03-16