BCI

Basic Information

• Brand Name: BCI
• Primary DI: 30610586038192
• Version / Model: 1151
• Company Name: SMITHS MEDICAL MD, INC.
• Labeler DUNS: 106712748
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-10-13
• Public Version: 7
• Public Version Date: 2020-02-13
• Public Version Status: Update
• Public Device Record Key: bbf29dad-0eab-420f-b4de-96f2aeba2d83

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCK	ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	Anesthesiology	868.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62698	Capnography sampling adaptor	A non-sterile device intended to enhance the capture of exhaled end-tidal carbon dioxide (EtCO2) for evaluation of a patient's ventilatory, circulatory, or metabolic status, typically during the administration of anaesthesia. It is an adhesive, dome-like adaptor with connecting ports designed to function as an interface between an in situ airway device (e.g., oropharyngeal airway, face mask, nasal oxygen cannula) and respiratory sampling tubing connected to a carbon dioxide monitor (capnograph). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30610586038192	GS1
Unit of Use	10610586038198	GS1

Premarket Submissions

Submission Number	Supplement Number
K871133	000