Kurin PIV Connection, w/ BioMerieux Shield & Pressure-Rated Extension Set

GUDID 00857606008172

Kurin, Inc.

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Primary Device ID00857606008172
NIH Device Record Keye5f9af3e-532f-4cdb-a505-609dd69fa9ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameKurin PIV Connection, w/ BioMerieux Shield & Pressure-Rated Extension Set
Version Model NumberM-PIV18
Company DUNS036018378
Company NameKurin, Inc.
Device Count200
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857606008172 [Primary]
GS110857606008179 [Package]
Package: Inner Carton [50 Units]
In Commercial Distribution
GS120857606008176 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JKATubes, Vials, Systems, Serum Separators, Blood Collection

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-29
Device Publish Date2018-09-28

Devices Manufactured by Kurin, Inc.

20857606008107 - Kurin Blood Culture Collection Set2023-07-31 PIV w/ Extension Set Lock Type = Non-Vented Set Length = 12"
20857606008220 - Kurin Blood Culture Collection Set2023-07-31 PIV, Lock Type = Non-Vented, Set Length = 4"
20857606008237 - Kurin Blood Culture Collection Set2023-07-31 PIV w/ Extension Set; Lock Type = Non-Vented, Set Length = 18", Blood Collection Holder = BD Vacutainer
20857606008244 - Kurin Blood Culture Collection Set2023-07-31 PIV w/ Extension Set, Lock Type = Non-Vented, Set Length = 18", Blood Collection Holder = BioMerieux
20857606008251 - Kurin Blood Culture Collection Set2023-07-31 PIV w/ Extension Set, Lock Type = Non-Vented, Set Length = 18", Blood Collection Holder = Short Saf-T Adapter
20857606008268 - Kurin Blood Culture Collection Set2023-07-31 Needle Gauge/Type = 21/Standard, Lock Type = Non-Vented, Set Length = 12", Blood Collection Holder = BD Vacutainer
20857606008282 - Kurin Blood Culture Collection Set2023-07-31 PIV, Lock Type = Non-Vented, Set Length = 12", Blood Collection Holder = Short Saf-T Adapter
20857606008299 - Kurin Blood Culture Collection Set2023-07-31 Needle Gauge/Type = 23/Push Button, Lock Type = Non-Vented, Set Length = 12", Blood Collection Holder = Short Saf-T Adapter

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