Pneupac

Basic Information

• Brand Name: Pneupac
• Primary DI: 15019517180367
• Version / Model: 530A1166NONEU
• Company Name: Smiths Medical ASD, Inc.
• Labeler DUNS: 082005361
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-25
• Public Version: 2
• Public Version Date: 2021-01-18
• Public Version Status: Update
• Public Device Record Key: 0966375a-197c-445c-84aa-938eb207d064

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: Yes
• MRI Safety: MR Conditional
• 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
BTL	Ventilator, emergency, powered (resuscitator)	Anesthesiology	868.5925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36289	Transport electric ventilator	An electrically-powered device designed to provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. It is typically a compact, lightweight, rugged device with internal batteries to power it during patient transport. It typically provides mandatory breaths at pre-set intervals (control mode), not allowing the patient to breathe spontaneously; operation in assist/control and/or synchronized intermittent mandatory ventilation (SIMV) modes is available in some types. It usually includes an airway pressure monitor and low and high pressure alarms; it may be used in ambulances, and in field hospitals.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15019517180367	GS1

Premarket Submissions

Submission Number	Supplement Number
K123957	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 465 – 1700 KiloPascal
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 465 – 1100 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 25 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 25 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -10 – 50 Degrees Celsius