AquaCast Mask

GUDID 04719879740172

AquaCast Mask is a device used for the positioning and immobilization of patient’s head undergoing or receiving a course of external beam radiation therapy for the treatment of cancer. Our AquaCast Masks are available in thicknesses of 2.4 mm and 3.2 mm. The thermoplastics extending 5cm and 7cm beyond the bottom of the plastic frames for U-frame, S-frame, V-frame masks are also available for land-marking.

BLESSING CATHAY CORPORATION

Patient positioning thermoplastic mould material

• Primary Device ID: 04719879740172
• NIH Device Record Key: f8b87906-bfcd-4a04-8db7-9de1f2763cd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AquaCast Mask
• Version Model Number: PUS-24
• Company DUNS: 658023267
• Company Name: BLESSING CATHAY CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719879740172 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252174

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2025-09-26
• Device Publish Date: 2025-09-18

Devices Manufactured by BLESSING CATHAY CORPORATION

• 04719879740172 - AquaCast Mask: 2025-09-26AquaCast Mask is a device used for the positioning and immobilization of patient’s head undergoing or receiving a course of external beam radiation therapy for the treatment of cancer. Our AquaCast Masks are available in thicknesses of 2.4 mm and 3.2 mm. The thermoplastics extending 5cm and 7cm beyond the bottom of the plastic frames for U-frame, S-frame, V-frame masks are also available for land-marking.
• 04719879740172 - AquaCast Mask: 2025-09-26 AquaCast Mask is a device used for the positioning and immobilization of patient’s head undergoing or receiving a course of ex
• 04719879740615 - Blessing Cathay: 2025-07-29
• 04719879741179 - Blessing Cathay: 2025-07-29
• 04719879741186 - Blessing Cathay: 2025-07-29
• 04719879741193 - Blessing Cathay: 2025-07-29
• 04719879741209 - Blessing Cathay: 2025-07-29
• 04719879741216 - Blessing Cathay: 2025-07-29
• 04719879741223 - Blessing Cathay: 2025-07-29