AIR CUSHIONED FACE MASK 132-685

GUDID 10718175005160

MASK, FACE, LARGE ADULT, WITHOUT INJECTION PORT (LATEX FREE)

BIODEX MEDICAL SYSTEMS, INC.

Xenon administration system, diagnostic nuclear medicine

• Primary Device ID: 10718175005160
• NIH Device Record Key: fe519169-6eae-4a8b-ad06-cdf9240bd91f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIR CUSHIONED FACE MASK
• Version Model Number: 132-685
• Catalog Number: 132-685
• Company DUNS: 043833813
• Company Name: BIODEX MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00718175005163 [Primary]
GS1	10718175005160 [Package]; Contains: 00718175005163; Package: Box [25 Units]; In Commercial Distribution

FDA Product Code

• IYT: System, Rebreathing, Radionuclide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-23
• Device Publish Date: 2019-12-13

On-Brand Devices [AIR CUSHIONED FACE MASK]

• 10718175005184: MASK, FACE, ADULT, AIR-CUSHIONED WITH DIRECT DOSE ADMINISTRATION (LATEX FREE)
• 10718175005177: MASK, FACE, ADULT, AIR-CUSHIONED WITH INJECTION PORT (LATEX FREE)
• 10718175005160: MASK, FACE, LARGE ADULT, WITHOUT INJECTION PORT (LATEX FREE)