900 Series Ventilator

Basic Information

• Brand Name: 900 Series Ventilator
• Primary DI: 10841522100055
• Version / Model: 700900VENT
• Catalog Number: 700900VENT
• Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC
• Labeler DUNS: 145581588
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-19
• Public Version: 7
• Public Version Date: 2019-06-19
• Public Version Status: Update
• Public Device Record Key: 4030b375-93a9-4ee2-a886-ab3a77686c18

Device Description

700/900 VENTILATORS

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: MR Unsafe
• 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
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47769	Anaesthesia unit, mobile	A stand-alone assembly of devices on wheels for mobility designed to continuously or intermittently administer a mixture of gases [e.g., oxygen (O2), ambient/medical air, nitrous oxide (N2O), anaesthetic agents] to provide a patient with an appropriate level of anaesthesia for a surgical procedure. Also known as an anaesthesia machine, it may include an oxygen concentrator or function with mounted medical gas cylinders, and typically has mechanical gas-delivery devices (e.g., flowmeters and vaporizers). It may incorporate a powered or manual anaesthesia ventilator, a patient breathing circuit, and gas monitoring devices; patient monitors are typically separately mounted (not integral).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841522100055	GS1