S-Monovette® 01.1624.001

GUDID 04038917228299

S-Monovette® 8.8 ml ACD-A

SARSTEDT, INC.

Evacuated blood collection tube IVD, acid citrate dextrose A (ACD-A)

• Primary Device ID: 04038917228299
• NIH Device Record Key: df29c612-448d-4bb4-90ba-383e3f1bcea9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S-Monovette®
• Version Model Number: 01.1624.001
• Catalog Number: 01.1624.001
• Company DUNS: 035410179
• Company Name: SARSTEDT, INC.
• Device Count: 50
• 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

Customer Support Contacts

• Phone: 800-257-5101
• Email: customerservice.us@sarstedt.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04038917228299 [Package]; Contains: 04038917228305; Package: [500 Units]; In Commercial Distribution
GS1	04038917228305 [Primary]
GS1	04038917228312 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-04-01
• Device Publish Date: 2016-09-22

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