Cyto-Chex BCT 213362

GUDID 20844509000826

A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 5 ml vials.

STRECK, INC.

Evacuated blood collection tube IVD, K3EDTA

• Primary Device ID: 20844509000826
• NIH Device Record Key: a3b1d4fb-54ef-4377-b9ba-5a4f5828ba72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cyto-Chex BCT
• Version Model Number: 213362
• Catalog Number: 213362
• Company DUNS: 072915986
• Company Name: STRECK, INC.
• Device Count: 25
• 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: 5 Milliliter
• Total Volume: 5 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	00844509000822 [Unit of Use]
GS1	20844509000826 [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: 2016-09-16

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