BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Patient cassette complete

DI: 17325710004095 · Model: 6680325 · Maquet Critical Care AB

View on AccessGUDID

Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

Basic Information

Brand Name: Patient cassette complete
Primary DI: 17325710004095
Version / Model: 6680325
Company Name: Maquet Critical Care AB
Labeler DUNS: 632707092
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2015-10-23
Public Version: 3
Public Version Date: 2018-07-06
Public Version Status: Update
Public Device Record Key: e3d349e7-2e9b-46cc-b413-42b9005f9c73

Device Characteristics

Single Use: No
Prescription Use (Rx): No
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: 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
BSZ	Gas-Machine, Anesthesia	Anesthesiology	868.5160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37710	Anaesthesia workstation, general-purpose	An assembly of electronic devices used for general inhalation anaesthesia (i.e., the delivery of oxygen (O2), nitrous oxide (N2O), other medical gases, and anaesthetic agents) and possibly total intravenous anaesthesia and local anaesthesia. Its main components are high, intermediate, and low pressure gas delivery systems, a breathing circuit (typically with a ventilator), and an anaesthetic gas scavenging system (AGSS). It has built-in alarms, analysers, control/monitoring systems, and typically has integrated circuitry/touchscreen displays for target controlled anaesthesia (TCA) for any type of patient (e.g., neonate, adult).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	07325710004098	GS1
Primary	17325710004095	GS1

Premarket Submissions

Submission Number	Supplement Number
K133958	000