Cyto-Chex BCT 230353

GUDID 40844509002206

A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 4ml vials.

STRECK, INC.

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

• Primary Device ID: 40844509002206
• NIH Device Record Key: da45e8b0-8355-409e-baac-2b61ac00ff2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cyto-Chex BCT
• Version Model Number: 230353
• Catalog Number: 230353
• Company DUNS: 072915986
• Company Name: STRECK, INC.
• Device Count: 1000
• 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: 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: 1-800-228-6090
• Email: custserv@streck.com
• Phone: 1-800-228-6090
• Email: custserv@streck.com

Device Dimensions

• Total Volume: 4 Milliliter
• Total Volume: 4 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	00844509002208 [Unit of Use]
GS1	40844509002206 [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: 2017-02-10

On-Brand Devices [Cyto-Chex BCT]

• 40844509002206: A direct-draw blood collection tube for the preservation of whole blood specimens for immunophen
• 30844509002209: A direct-draw blood collection tube for the preservation of whole blood specimens for immunophen
• 30844509000823: A direct-draw blood collection tube for the preservation of whole blood specimens for immunophen
• 20844509002202: A direct-draw blood collection tube for the preservation of whole blood specimens for immunophen
• 20844509000833: A direct-draw blood collection tube for the preservation of whole blood specimens for immunophen
• 20844509000826: A direct-draw blood collection tube for the preservation of whole blood specimens for immunophen