Model: GFM50-MD2201
DI: 04712978252065
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
46b5f76d-66ff-47fe-9eec-c77052b35559
Distribution Status:
In Commercial Distribution
DUNS Number:
656127743
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04712978252065
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47083
Name: Portable electric ventilator
Definition:
A portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).
FDA Product Codes
MNS
Ventilator, Continuous, Non-Life-Supporting
Premarket Submissions
Submission Number:
K252078
Supplement Number:
000