8,5 ml Urine Monovette

GUDID 04038917992428

Sarstedt Aktiengesellschaft & Co.KG

Non-evacuated urine specimen container IVD, no additive

• Primary Device ID: 04038917992428
• NIH Device Record Key: 2d405056-59e3-4cea-80a0-5101e40ef257
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 8,5 ml Urine Monovette
• Version Model Number: 10.258.061
• Company DUNS: 388000270
• Company Name: Sarstedt Aktiengesellschaft & Co.KG
• Device Count: 64
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04038917992428 [Unit of Use]
GS1	04038917992435 [Primary]

FDA Product Code

• NNK: Container, Specimen Mailer And Storage, Non-Sterile

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-04
• Device Publish Date: 2024-10-25

On-Brand Devices [8,5 ml Urine Monovette]

• 04038917992541: 10.258.081
• 04038917992428: 10.258.061