ProtekDuo

GUDID 00814112020456

Vascular dilator, single-use

Primary Device ID	00814112020456
NIH Device Record Key	40b8ac49-36af-4264-901f-5db5193e8dc0
Commercial Distribution Status	In Commercial Distribution
Brand Name	ProtekDuo
Version Model Number	5100-1426
Company DUNS	948683941
Company Name	CARDIACASSIST, 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	false
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	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00814112020456 [Primary]

DRE	Dilator, Vessel, For Percutaneous Catheterization

Steralize Prior To Use	false
Device Is Sterile	true

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00814112020548	TandemHeart Blood Pump Kit with 31 Fr Mini Veno-Venous Cannula
00814112020531	31 Fr x 36 cm Dual Lumen VV Cannula Set
00814112020456	Four 25 cm Dilators (14 Fr, 18 Fr, 22 Fr, and 26 Fr)
00814112020418	TandemHeart blood pump kit with 31 Fr veno-venous cannula
00814112020401	TandemHeart blood pump kit with 29 Fr veno-venous cannula
00814112020319	31 Fr x 51 cm Veno-Venous Dual Lumen Cannula with Introducer