bcI

Basic Information

• Brand Name: bcI
• Primary DI: 00695085800210
• Version / Model: 7204045
• Company Name: SMITHS MEDICAL MD, INC.
• Labeler DUNS: 106712748
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-13
• Public Version: 4
• Public Version Date: 2018-08-17
• Public Version Status: Update
• Public Device Record Key: 7946f2f0-1454-4c5e-bc07-ce51fb419ba3

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
KZL	DEVICE, WARMING. BLOOD AND PLASMA	Hematology	864.9205	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38468	Intravenous pressure infusor, automated	A pneumatically-powered device designed to increase the rate of an intravenous (IV) infusion given to a patient by applying pressure directly to the infusion bag. The device is designed with a pressure chamber into which the infusion bag is secured, and is connected to a supply of pressurized air which, when activated, creates pressure in the rear of the chamber. It typically includes a pressure gauge to indicate the applied pressure and overpressure safety features.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00695085800210	GS1

Premarket Submissions

Submission Number	Supplement Number
BK860023	000