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Devices
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.
1 Event
Recall of ComfortGel Nasal Mask
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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
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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
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.
COMFORTGEL NASAL MASK
Model / Serial
Model Catalog: (Lot serial: ALL)
Product Classification
Anesthesiology Devices
Product Description
COMFORTGEL NASAL MASK 1009041/1009042
Manufacturer
RESPIRONICS INC.
Language
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