FDA.reportPublic FDA data

Automated PD Set DS-1.B

Primary DI
08964004471032
Brand
Automated PD Set DS-1.B
Company
BYONYKS PRIVATE LIMITED
Model
1F1501
Catalog number
1F1501
Device description
This Byonyks Automated PD Set DS-1.B is compatible with the Byonyks X-1 APD Cycler.
Published
2025-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KDJSet, Administration, For Peritoneal Dialysis, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDJSet, Administration, For Peritoneal Dialysis, DisposableGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08964004471049PackageGS17In Commercial Distribution
08964004471032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08964004471049089640044710498964004471049
08964004471032089640044710328964004471032

GMDN Terms#

Term, Definition table
TermDefinition
Peritoneal dialysis system tubing setA sterile set intended for the administration of peritoneal dialysis. It will typically consist of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysis filter to trap and remove contaminating particles. This is a single-use device.

Regulatory Flags#

DUNS number
645843231
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08964004471049Automated PD Set DS-1.B1F15011F15012025-11-13
08964004471018Automated PD Set DS-11F12011F12012025-09-08
08964004471001X-1 APD Cycler1B12071B12072025-09-08
08964004471025Automated PD Set DS-11F12011F12012025-09-08

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Primary DI, Brand, Company table
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08964004471049Automated PD Set DS-1.BBYONYKS PRIVATE LIMITEDKDJ2025-11-13
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