BCI

Basic Information

• Brand Name: BCI
• Primary DI: 35019517042584
• Version / Model: 3135
• Company Name: SMITHS MEDICAL MD, INC.
• Labeler DUNS: 106712748
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-10-13
• Public Version: 5
• Public Version Date: 2018-10-17
• Public Version Status: Update
• Public Device Record Key: e4cfc364-3ceb-4b19-ac99-19e573b96875

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQO	CATHETER, INTRAVASCULAR, DIAGNOSTIC	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17812	Needle guard	A cap/cover intended to be extended over a used needle (attached to a syringe/autoinjector or not) to prevent accidental needle sticks, typically during removal of the needle. It is typically a plastic housing with appropriate shielding to prevent injury upon application, and is typically disposed of with the needle; it is not the needle cap provided with the needle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	35019517042584	GS1
Unit of Use	15019517042580	GS1

Premarket Submissions

Submission Number	Supplement Number
K893877	000