SLT IVUS P1 Display Unit DU0001

GUDID 00850045446031

Cardiovascular ultrasound imaging system

Primary Device ID	00850045446031
NIH Device Record Key	6763dc11-33ce-476c-b6ee-3de1992f40d8
Commercial Distribution Status	In Commercial Distribution
Brand Name	SLT IVUS P1 Display Unit
Version Model Number	DU0001
Catalog Number	DU0001
Company DUNS	015877254
Company Name	Provisio Medical, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00850045446031 [Primary]

OBJ	Catheter, Ultrasound, Intravascular

Steralize Prior To Use	false
Device Is Sterile	false

00850045446000 - SLT IVUS P1 Pulser Receiver Unit	2024-06-03 See LBL-0998, SLT IVUS P1 System Manual
00850045446024 - SLT IVUS Support Crossing Catheter	2024-06-03 The SLT IVUS Support Crossing Catheters are over-the-wire intravascular ultrasound catheters with a digital ultrasound transduce
00850045446031 - SLT IVUS P1 Display Unit	2024-06-03See LBL-0998, SLT IVUS P1 System Manual
00850045446031 - SLT IVUS P1 Display Unit	2024-06-03 See LBL-0998, SLT IVUS P1 System Manual
00850045446048 - SLT IVUS P1 Cart	2024-06-03 See LBL-0998, SLT IVUS P1 System Manual