Prelude IDeal™ Hydrophilic Sheath K21-00046

GUDID 20884450474062

Vascular catheter introduction set, nonimplantable

Primary Device ID	20884450474062
NIH Device Record Key	8563179f-c38b-43bc-a4e3-5355d9fc55b6
Commercial Distribution Status	In Commercial Distribution
Brand Name	Prelude IDeal™ Hydrophilic Sheath
Version Model Number	00884450474068
Catalog Number	K21-00046
Company DUNS	184763290
Company Name	Merit Medical Systems, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	false
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	00884450474068 [Primary]
GS1	10884450474065 [Package] Contains: 00884450474068 Package: [5 Units] In Commercial Distribution
GS1	20884450474062 [Package] Contains: 10884450474065 Package: [4 Units] In Commercial Distribution

OEX	Cardiovascular catheter sheath introducer kit

Steralize Prior To Use	false
Device Is Sterile	true