BD Vacutainer® CPT™ NC: 1.0mL FICOLL™: 2.0mL

Basic Information

• Brand Name: BD Vacutainer® CPT™ NC: 1.0mL FICOLL™: 2.0mL
• Primary DI: 50382903627610
• Version / Model: 362761
• Catalog Number: 362761
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 001292192
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 60
• Record Status: Published
• Publish Date: 2016-08-22
• Public Version: 4
• Public Version Date: 2023-08-10
• Public Version Status: Update
• Public Device Record Key: 0c54884a-1aa0-4672-a44b-ed789d3f34f2

Device Description

TUBE CPTCIT GC 16X125 8.0 MLBL BL/BLK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JKA	Tubes, vials, systems, serum separators, blood collection	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65457	Evacuated blood collection tube IVD, anticoagulant/separator/density solution	A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), sodium heparin, sodium citrate, potassium oxalate], a separator (e.g., gel or elastomer) to separate plasma from bloods cells, and density solution to isolate plasma and mononuclear cells from other whole blood components. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., mononuclear cell analysis, plasma chemistry determinations). Additional blood freezing tubes (cryovials) may be supplied with the device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	50382903627610	GS1
Unit of Use	00382903627615	GS1

Premarket Submissions

Submission Number	Supplement Number
K911731	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 18 – 25 Degrees Celsius