NA

Basic Information

• Brand Name: NA
• Primary DI: 00613994258090
• Version / Model: BD14
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-06-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 449796df-eb3c-406b-bd37-1587597846b3

Device Description

DETECTOR BD14 BUBBLE PEDIATRIC

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: 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
DWA	Control, pump speed, cardiopulmonary bypass	Cardiovascular	870.4380	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35440	Cardiopulmonary bypass system air bubble/fluid level detector	A mains electricity (AC-powered) device designed to detect air bubbles in blood returned to the body from the extracorporeal circuit of a cardiopulmonary (heart-lung) bypass system, and to detect when blood falls below acceptable levels, typically in the venous drip chamber. The device typically consists of an electronic unit and ultrasonic sensors; it usually triggers alarms and activates automated mechanisms to turn off the blood flow when bubbles are detected or an abnormal fluid level occurs. It is typically an integral part of the cardiopulmonary bypass system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00613994258090	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K070286	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 66 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Atmospheric Limitation of 700 hPa to 1060 hPa
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity