Kurin 21 Gauge, Push Button Needle w/12" Tubing, BD Vacutainer

GUDID 00857606008028

Kurin, Inc.

Blood collection set, invasive
Primary Device ID00857606008028
NIH Device Record Key58a9d4e2-6fa9-4ce2-988a-f4bd765cfa67
Commercial Distribution StatusIn Commercial Distribution
Brand NameKurin 21 Gauge, Push Button Needle w/12" Tubing, BD Vacutainer
Version Model NumberD-21221
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
GS100857606008028 [Primary]
GS110857606008025 [Package]
Package: Inner Carton [50 Units]
In Commercial Distribution
GS120857606008022 [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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