FDA.reportPublic FDA data

AquaCast Mask

Primary DI
04719879740172
Brand
AquaCast Mask
Company
BLESSING CATHAY CORPORATION
Model
PUS-24
Device description
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.
Published
2025-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252174000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252174000AquaCast MaskBlessing Cathay Corporation2025-09-03IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719879740172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719879740172047198797401724719879740172

GMDN Terms#

Term, Definition table
TermDefinition
Patient positioning thermoplastic mould materialA thermoplastic material used to create moulds of a patient's body. It is commonly supplied as sheets or meshes of thermoplastic material that have been coated with polyurethane for ease of handling and positioning. Most of these materials are softened by heating in hot water and while softened, are moulded around the patient's anatomy. When cooled, it hardens to form a custom-made mould or cast of that part of the body. After the moulding process is complete, it is typically attached to a board, frame, or another patient positioning system (PPS) or immobilization device. After application, this device cannot be reused (i.e., remoulded).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658023267
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719879742367Blessing CathayTIMO-A2026-06-22
04719879742374Blessing CathayTIMO-B2026-06-22
04719879742381Blessing CathayTIMO-C2026-06-22
04719879742398Blessing CathayTIMO-D2026-06-22
04719879742404Blessing CathayTIMO-E2026-06-22
04719879742411Blessing CathayTIMO-F2026-06-22
04719879740615Blessing CathaySILVER-F2025-07-21
04719879741179Blessing CathaySILVER-B2025-07-21
04719879741186Blessing CathaySILVER-B2025-07-21
04719879741193Blessing CathaySILVER-C2025-07-21
04719879741209Blessing CathaySILVER-C2025-07-21
04719879741216Blessing CathaySILVER-D2025-07-21
04719879741223Blessing CathaySILVER-D2025-07-21
04719879741230Blessing CathaySILVER-E2025-07-21
04719879741247Blessing CathaySILVER-E2025-07-21
04719879741162Blessing CathaySILVER-A2025-07-11
04719879741285Blessing CathayTIMO-C-AS2025-07-10
04719879741261Blessing CathayTIMO-A-AS2025-07-09
04719879741278Blessing CathayTIMO-B-AS2025-07-09
04719879741292Blessing CathayTIMO-D-AS2025-07-09

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