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DEPARTMENT OF HEALTH & HUMAN SERVICES Public

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Standards for EMS Equipment**

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Annex 1 Lot 4 (Medical Accessories & Consummables)

Item 4.03 Ambubag Technical Specifications General requirements: Each device shall be CE marked, 93/42/CEE, or FDA approved for medical use, when applicable. The Supplier shall be ISO 9001. Each Manufacturer shall be ISO 13485 Certified. Copy of the above mentioned CE mark 93/42/CEE, or FDA approval and ISO certifications shall be included in the offer.Suppliers page 818 of medical products / servicesProducts: Anesthetic Gas Mask (FDA Code: BSJ), Tracheobronchial Suction Catheter (FDA Code: BSY), Non-Powered Portable Single Patient Suction Apparatus (FDA Code: GCY), Vacuum Abortion System (FDA Code: HHI), Fixed Size Cervical Dilator (FDA Code: HDQ), Uterine Suction Cannula (FDA Disposable - AUG MEDICAL LLCTextured bag allows positive grip, 360° swivel for ease of use with facemask or endotracheal tube Clear non-rebreathing valve Children/infant bags complete with 40cm H2O safety pressure release valve, minimizes the risk of over inflating the lungs Folds into compact size to help storage

Symbols Commonly Used in Medical Device Packaging

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