Monovette® 1ml LH

GUDID 04038917408622

Sarstedt Aktiengesellschaft & Co.KG

Non-evacuated blood collection tube IVD, anticoagulant

• Primary Device ID: 04038917408622
• NIH Device Record Key: c575be7a-1da5-4035-a803-2941280208b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monovette® 1ml LH
• Version Model Number: 05.1146.008
• Company DUNS: 388000270
• Company Name: Sarstedt Aktiengesellschaft & Co.KG
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04038917408615 [Primary]
GS1	04038917408622 [Unit of Use]

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: 2024-10-15
• Device Publish Date: 2024-10-07

On-Brand Devices [Monovette® 1ml LH]

• 04038917408622: 05.1146.008
• 04066916040338: 05.1146.148
• 04066916037154: 05.1146.120