BMU 40

Basic Information

• Brand Name: BMU 40
• Primary DI: 04037691676203
• Version / Model: Y-Datacable kit (Lemo auf 2 x DE9f)
• Catalog Number: 70104.5532
• Company Name: Maquet Cardiopulmonary AG
• Labeler DUNS: 316153865
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-13
• Public Version: 4
• Public Version Date: 2021-09-28
• Public Version Status: Update
• Public Device Record Key: daf23ddc-1c80-4643-8ff8-413eb41f98b6

Device Description

Y-Datacable kit (LEMO 2 x DE9 female) incl. adaptor kit. RS232-Isolator 4KV. The blood monitoring unit BMU 40 is used to monitor the patient’s key blood levels during extracorporeal circulation. On the basis of the blood levels, the user can immediately adjust the settings of the equipment being used, thereby increasing patient safety.

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: 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
DRY	MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS	Cardiovascular	870.4330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37238	Extracorporeal blood gas/pH monitor	A mains electricity (AC-powered) device designed for the continuous measurement and display of blood gas and related parameters when blood is circulated outside of the body in a closed system. It is typically used with an appropriate sensor or sensor cassette inserted into external tubing to measure parameters such as partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, temperature, haemoglobin (Hb), and hematocrit (Hct). It is typically used with a cardiopulmonary bypass system, or bedside for a patient with respiratory failure (e.g., obstructive lung disease, severe asthma) or severe pulmonary hypertension after cardiac surgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04037691676203	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K090147	000