Monovette® 2ml LH

GUDID 04038917199988

Sarstedt Aktiengesellschaft & Co.KG

Non-evacuated blood collection tube IVD, anticoagulant

• Primary Device ID: 04038917199988
• NIH Device Record Key: 04c342ee-fb1d-4d6b-ac19-2a54779898f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monovette® 2ml LH
• Version Model Number: 05.1147.008
• 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	04038917125956 [Primary]
GS1	04038917199988 [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

Devices Manufactured by Sarstedt Aktiengesellschaft & Co.KG

• 04066916037154 - Monovette® 1ml LH: 2025-07-10
• 04066916037543 - BloodGas Monovette®2ml: 2025-07-10
• 04066916037581 - BloodGas Monovette®2ml Adapter: 2025-07-10
• 04066916039806 - BloodGas Monovette®2ml Ventilat: 2025-07-10
• 04066916040338 - Monovette® 1ml LH: 2025-07-10
• 04038917168304 - Urine receptacle 500ml: 2025-05-27
• 04038917530606 - Safety-Needle 23Gx1": 2025-05-12
• 04038917182942 - Urine Monovette 10 ml: 2025-04-18