Pneupac

Basic Information

• Brand Name: Pneupac
• Primary DI: 10610586045752
• Version / Model: WW331002S
• Company Name: SMITHS MEDICAL MD, INC.
• Labeler DUNS: 106712748
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-21
• Public Version: 4
• Public Version Date: 2018-08-17
• Public Version Status: Update
• Public Device Record Key: efa40db0-e3d3-43be-8f15-4099c667a9ac

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: No
• 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
60944	Medical air cylinder regulator	A reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a medical air cylinder to lower high, variable gas pressure (e.g., 50 - 250 bar) to a lower, constant working pressure (typically 3 - 5 bar). It can be a single- or dual-stage regulator, usually of a piston or diaphragm design. It includes a safety relief valve to avoid excessive pressure due to increased ambient temperatures, and it may include associated devices, usually a manometer(s), to display the available gas reserve of the air cylinder and the working pressure.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10610586045752	GS1

Premarket Submissions

Submission Number	Supplement Number
K020899	000