Kurin 21 Gauge, Standard Needle w/12" Tubing, BioMerieux Shield

GUDID 00857606008059

Kurin, Inc.

Blood collection set, invasive

• Primary Device ID: 00857606008059
• NIH Device Record Key: c7e47adc-cb19-4c6f-ad6a-36957378090c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kurin 21 Gauge, Standard Needle w/12" Tubing, BioMerieux Shield
• Version Model Number: M-11221
• 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	00857606008059 [Primary]
GS1	10857606008056 [Package]; Package: Inner Carton [50 Units]; In Commercial Distribution
GS1	20857606008053 [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: 2018-10-29
• Device Publish Date: 2018-09-28

Devices Manufactured by Kurin, Inc.

• 20857606008107 - Kurin Blood Culture Collection Set: 2023-07-31 PIV w/ Extension Set Lock Type = Non-Vented Set Length = 12"
• 20857606008220 - Kurin Blood Culture Collection Set: 2023-07-31 PIV, Lock Type = Non-Vented, Set Length = 4"
• 20857606008237 - Kurin Blood Culture Collection Set: 2023-07-31 PIV w/ Extension Set; Lock Type = Non-Vented, Set Length = 18", Blood Collection Holder = BD Vacutainer
• 20857606008244 - Kurin Blood Culture Collection Set: 2023-07-31 PIV w/ Extension Set, Lock Type = Non-Vented, Set Length = 18", Blood Collection Holder = BioMerieux
• 20857606008251 - Kurin Blood Culture Collection Set: 2023-07-31 PIV w/ Extension Set, Lock Type = Non-Vented, Set Length = 18", Blood Collection Holder = Short Saf-T Adapter
• 20857606008268 - Kurin Blood Culture Collection Set: 2023-07-31 Needle Gauge/Type = 21/Standard, Lock Type = Non-Vented, Set Length = 12", Blood Collection Holder = BD Vacutainer
• 20857606008282 - Kurin Blood Culture Collection Set: 2023-07-31 PIV, Lock Type = Non-Vented, Set Length = 12", Blood Collection Holder = Short Saf-T Adapter
• 20857606008299 - Kurin Blood Culture Collection Set: 2023-07-31 Needle Gauge/Type = 23/Push Button, Lock Type = Non-Vented, Set Length = 12", Blood Collection Holder = Short Saf-T Adapter