Cyto-Chex® BCT 230377

GUDID 40844509000837

A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 2 ml vials.

STRECK, INC.

Evacuated blood collection tube IVD, K3EDTA Evacuated blood collection tube IVD, K3EDTA

• Primary Device ID: 40844509000837
• NIH Device Record Key: 80e6f831-c9ae-4a00-96d7-34fbd1116b26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cyto-Chex® BCT
• Version Model Number: 230377
• Catalog Number: 230377
• Company DUNS: 072915986
• Company Name: STRECK, INC.
• Device Count: 100
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 1-800-228-6090
• Email: custserv@streck.com
• Phone: 1-800-228-6090
• Email: custserv@streck.com

Device Dimensions

• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844509000839 [Unit of Use]
GS1	40844509000837 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080552

FDA Product Code

• GIM: Tubes, Vacuum Sample, With Anticoagulant

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: 2018-07-06
• Device Publish Date: 2017-08-15

On-Brand Devices [Cyto-Chex® BCT]

• 40844509000837: A direct-draw blood collection tube for the preservation of whole blood specimens for immunophen
• 30844509000830: A direct-draw blood collection tube for the preservation of whole blood specimens for immunophen