Monarch 21G BCS

GUDID 00850058273037

Safety blood Collection Set 21g, 3/4" Needle, 12" tubing, with luer adapter

THE MONARCH CO., LLC

Blood collection set, invasive

• Primary Device ID: 00850058273037
• NIH Device Record Key: f6b9716a-f52d-4b28-b481-c4bd8f57ca81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monarch 21G BCS
• Version Model Number: M2112L
• Company DUNS: 119086771
• Company Name: THE MONARCH CO., LLC
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850058273037 [Unit of Use]
GS1	10850058273034 [Primary]
GS1	20850058273031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232308

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: 2024-01-25
• Device Publish Date: 2024-01-17

On-Brand Devices [Monarch 21G BCS]

• 00850058273075: Safety Blood Collection 21g, 3/4" Needle, 12" tubing, with luer slip holder
• 00850058273136: Safety Blood collection set 21g, 3/4" Needle, 12" tubing, with luer lock holder
• 00850058273037: Safety blood Collection Set 21g, 3/4" Needle, 12" tubing, with luer adapter