Introducer Kit for Impella® 0052-3025

GUDID 00885672009793

Vascular catheter introduction set, nonimplantable

Primary Device ID	00885672009793
NIH Device Record Key	6a017a1f-101e-403e-b956-4ff4573ed768
Commercial Distribution Status	In Commercial Distribution
Brand Name	Introducer Kit for Impella®
Version Model Number	0052-3025
Catalog Number	0052-3025
Company DUNS	101835833
Company Name	Oscor Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00885672009793 [Primary]

DYB	INTRODUCER, CATHETER

Steralize Prior To Use	false
Device Is Sterile	true

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