Monsoon III Laserjet 70

Basic Information

• Brand Name: Monsoon III Laserjet 70
• Primary DI: 07640140860749
• Version / Model: 255105
• Company Name: Acutronic Medical Systems AG
• Labeler DUNS: 481327922
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-20
• Public Version: 1
• Public Version Date: 2023-01-30
• Public Version Status: New
• Public Device Record Key: c07bd12e-2594-4e25-b14d-c7e08230fd7e

Device Description

Laserjet 70, double lumen jet catheter acc. Biro, 70 cm length

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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	868.5895	2
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	868.5450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36231	Oxygen administration transtracheal catheter	A flexible tube intended to be introduced across the tracheal wall to provide supplementary oxygen (O2) to the respiratory tract of a person who is unable to breathe through the nose or mouth because of obstruction. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640140860749	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K012691	000