BD Seditainer™ Buff.Na Citrate 0.105M 1.25ml

Basic Information

• Brand Name: BD Seditainer™ Buff.Na Citrate 0.105M 1.25ml
• Primary DI: 50382903660655
• Version / Model: 366065
• Catalog Number: 366065
• Company Name: Becton, Dickinson U.K. Limited
• Labeler DUNS: 225931062
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2016-07-28
• Public Version: 4
• Public Version Date: 2023-08-10
• Public Version Status: Update
• Public Device Record Key: e95db095-4653-472b-a1c4-2845d953a5d3

Device Description

BD Seditainer™ Buff.Na Citrate 0.105M 1.25ml

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: No
• 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
37558	Evacuated erythrocyte sedimentation rate (ESR) tube IVD	A sterile glass or plastic tube sealed with a stopper, or other dedicated vessel, containing a pre-measured amount of vacuum and the blood anticoagulant sodium citrate. It is intended to be used alone or in combination with other IVDs (e.g., ESR analyser, scaled measure) for the quantitative determination of the erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	50382903660655	GS1
Unit of Use	00382903660650	GS1

Premarket Submissions

Submission Number	Supplement Number
K953994	000