Devices

Device Recall Mask adult, oxygen, medium concentration, elastic strap & nonbreathing

Model / Serial
Lot 030711; Product code: 8110-7-50, Product code: 8130-7-50; Product code: E8149-7-50.
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, medium concentration, elastic strap style w. 7' tube (Linde) 50/cs || Mask, adult, oxygen, high concentration, non-rebreathing, elastic strap style w/ 7' tube and safety vent - 50/cs; || Mask adult, oxygen, high concentration, non-rebreathing, w/7' tube w/out 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, elastic strap & 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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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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