Devices

Device Recall Mask adult, oxygen, medium concentration, nonbreathing

Model / Serial
Lot 031411; Product code: 8130-9-25; Product code: 8130-0-50; Product Code: E8139-7-50.
Product Classification
Anesthesiology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Colombia and Iceland.
Product Description
Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w/9' tube and safety vent - 50/cs; || Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w safety vent - 50/cs; || Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w/7' tube and safety vent - 50/cs; || Salter Labs, Arvin, CA 93203 || Intended usage: respiratory therapy.
Manufacturer
Salter Laboratories, Division of Regulatory Affairs
1 Event
- Recall of Device Recall Mask adult, oxygen, medium concentration, nonbreathing

Manufacturer

Salter Laboratories, Division of Regulatory Affairs

Manufacturer Address
Salter Laboratories, Division of Regulatory Affairs, 100 Sycamore Rd, Arvin CA 93203-2300
Source
USFDA

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