Devices

ComfortGel Nasal Mask

Model / Serial
Part number 1009041; Lot numbers 030612, 030418, 030417, 030415, 030409, 030321, 030320, 030316, 030312, 030311, 030310, 030306, 030305, 030303, and 030228.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
The products were shipped to sleep centers nationwide and in Canada.
Product Description
ComfortGel Nasal Mask size small
Manufacturer
Respironics, Inc.
1 Event
- Recall of ComfortGel Nasal Mask

Manufacturer

Respironics, Inc.

Manufacturer Address
Respironics, Inc., 1001 Murry Ridge Lane, Murrysville PA 15668
Source
USFDA

3 devices with a similar name

Learn more about the data here

ComfortGel Nasal Mask

Model / Serial
Part number 1009043; Lot numbers 030826, 030814, 030528, 030307, and 020822.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
The products were shipped to sleep centers nationwide and in Canada.
Product Description
ComfortGel Nasal Mask size large
Manufacturer
Respironics, Inc.

ComfortGel Nasal Mask

Model / Serial
Part number 1009042; Lot numbers 030604, 030603, 030528, 030520, 030501, 030422, 030421, 030408, 030325, 030319, 030314, 030312, 030311, 030227, 030226, 020826, and 020823.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
The products were shipped to sleep centers nationwide and in Canada.
Product Description
ComfortGel Nasal Mask size medium
Manufacturer
Respironics, Inc.

COMFORTGEL NASAL MASK

Model / Serial
Model Catalog: (Lot serial: ALL)
Product Classification
Anesthesiology Devices
Product Description
COMFORTGEL NASAL MASK 1009041/1009042
Manufacturer
RESPIRONICS INC.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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