Introducer Kit for Impella® 0052-3001

GUDID 00885672009731

Hemostatic Peel Away Introducer System with Infusion Sideport, 23F

Oscor Inc.

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Primary Device ID00885672009731
NIH Device Record Keyed618206-7177-48a0-9e8d-67ff4c8b906c
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntroducer Kit for Impella®
Version Model Number0052-3001
Catalog Number0052-3001
Company DUNS101835833
Company NameOscor Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com

Device Dimensions

Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100885672009731 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-02
Device Publish Date2019-09-24

On-Brand Devices [Introducer Kit for Impella®]

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00813502011562Hemostatic Peel Away Introducer System with Infusion Sideport, 14F
00813502011517Hemostatic Peel Away Introducer System with Infusion Sideport, 23F
00813502010664Hemostatic Peel Away Introducer System with Infusion Sideport, 13 cm and 25 cm
00813502010558Hemostatic Peel Away Introducer System with Infusion Sideport, 23F
00813502010244Hemostatic Peel Away Introducer System with Infusion Sideport, 14F
00813502010237Hemostatic Peel Away Introducer System with Infusion Sideport, 14F
00885672009793Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13 cm and 25 cm
00885672009786Hemostatic Peel Away Introducer System with Infusion Sideport, 23F
00885672009779Hemostatic Peel Away Introducer System with Infusion Sideport, 14F
00885672009762Hemostatic Peel Away Introducer System with Infusion Sideport, 14F
00885672009755Hemostatic Peel Away Introducer System with Infusion Sideport, 23F
00885672009748Hemostatic Peel Away Introducer System with Infusion Sideport, 14F
00885672009731Hemostatic Peel Away Introducer System with Infusion Sideport, 23F

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