Kurin Blood Culture Collection Set

GUDID 20857606008367

Needle Gauge/Type = 21/Standard, Lock Type = Non-Vented, Set Length = 12", Blood Collection Holder = BioMerieux

Kurin, Inc.

Blood collection set, invasive

• Primary Device ID: 20857606008367
• NIH Device Record Key: 7cd9356a-7fe4-4c06-8298-ed1c1d02e235
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kurin Blood Culture Collection Set
• Version Model Number: MJ-221
• Company DUNS: 036018378
• Company Name: Kurin, Inc.
• Device Count: 200
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00857606008363 [Primary]
GS1	20857606008367 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162233

FDA Product Code

• JKA: Tubes, Vials, Systems, Serum Separators, Blood Collection

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-31
• Device Publish Date: 2023-07-21

On-Brand Devices [Kurin Blood Culture Collection Set]

• 20857606008411: Needle Gauge/Type = 23/Standard, Lock Type = Non-Vented, Set Length = 12", Blood Collection Hold
• 20857606008404: Needle Gauge/Type = 23/Standard, Lock Type = Non-Vented, Set Length = 12", Blood Collection Hold
• 20857606008398: Needle Gauge/Type = 21/Push Button, Lock Type = Non-Vented, Set Length = 12", Blood Collection H
• 20857606008381: Needle Gauge/Type = 23/Push Button, Lock Type = Non-Vented, Set Length = 12", Blood Collection H
• 20857606008374: PIV, Lock Type = Non-Vented, Set Length = 12", Blood Collection Holder = BD Vacutainer
• 20857606008367: Needle Gauge/Type = 21/Standard, Lock Type = Non-Vented, Set Length = 12", Blood Collection Hold
• 20857606008350: Needle Gauge/Type = 23/Push Button, Lock Type = Non-Vented, Set Length = 12", Blood Collection H
• 20857606008329: PIV, Lock Type = Non-Vented, Set Length = 12", Blood Collection Holder = BioMerieux
• 20857606008312: Needle Gauge/Type = 23/Standard, Lock Type = Non-Vented, Set Length = 12", Blood Collection Hold
• 20857606008305: Needle Gauge/Type = 21/Push Button, Lock Type = Non-Vented, Set Length = 12", Blood Collection H
• 20857606008299: Needle Gauge/Type = 23/Push Button, Lock Type = Non-Vented, Set Length = 12", Blood Collection H
• 20857606008282: PIV, Lock Type = Non-Vented, Set Length = 12", Blood Collection Holder = Short Saf-T Adapter
• 20857606008268: Needle Gauge/Type = 21/Standard, Lock Type = Non-Vented, Set Length = 12", Blood Collection Hold
• 20857606008251: PIV w/ Extension Set, Lock Type = Non-Vented, Set Length = 18", Blood Collection Holder = Short
• 20857606008244: PIV w/ Extension Set, Lock Type = Non-Vented, Set Length = 18", Blood Collection Holder = BioMer
• 20857606008237: PIV w/ Extension Set; Lock Type = Non-Vented, Set Length = 18", Blood Collection Holder = BD Vac
• 20857606008220: PIV, Lock Type = Non-Vented, Set Length = 4"
• 20857606008107: PIV w/ Extension Set Lock Type = Non-Vented Set Length = 12"