FDA.reportPublic FDA data

Automated PD Set DS-1

Primary DI
08964004471018
Brand
Automated PD Set DS-1
Company
BYONYKS PRIVATE LIMITED
Model
1F1201
Catalog number
1F1201
Device description
This Byonyks Automated PD Set DS-1 is compatible with the Byonyks X-1 APD Cycler.
Published
2025-09-08
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
08964004471025PackageGS17In Commercial Distribution
08964004471018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08964004471025089640044710258964004471025
08964004471018089640044710188964004471018

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08964004471032Automated PD Set DS-1.B1F15011F15012025-11-13
08964004471049Automated PD Set DS-1.B1F15011F15012025-11-13
08964004471001X-1 APD Cycler1B12071B12072025-09-08
08964004471025Automated PD Set DS-11F12011F12012025-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332414208011FLEXICAP DISCONNECT CAP WITH POVIDONE-IODINE SOLUTIONVantive US Healthcare LLCKDJ2026-01-30
07332414208264MinicapVantive US Healthcare LLCKDJ2026-01-30
57332414208016FLEXICAP DISCONNECT CAP WITH POVIDONE-IODINE SOLUTIONVantive US Healthcare LLCKDJ2026-01-30
57332414208269MinicapVantive US Healthcare LLCKDJ2026-01-30
08964004471032Automated PD Set DS-1.BBYONYKS PRIVATE LIMITEDKDJ2025-11-13
08964004471049Automated PD Set DS-1.BBYONYKS PRIVATE LIMITEDKDJ2025-11-13
07332414207946LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETERVantive US Healthcare LLCKDJ2025-09-23
27332414207940LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETERVantive US Healthcare LLCKDJ2025-09-23
08964004471025Automated PD Set DS-1BYONYKS PRIVATE LIMITEDKDJ2025-09-08
07332414207939CYCLER DRAINAGE BAGBAXTER HEALTHCARE CORPORATIONKDJ2025-03-20
57332414207934CYCLER DRAINAGE BAGBAXTER HEALTHCARE CORPORATIONKDJ2025-03-20
00085412841625MINICAP EXTENDED LIFE PD TRNSBAXTER HEALTHCARE CORPORATIONKDJ2024-08-05
20085412841629MINICAP EXTENDED LIFE PD TRNSBAXTER HEALTHCARE CORPORATIONKDJ2024-08-05
00085412722894Cycler Drainage BagBAXTER HEALTHCARE CORPORATIONKDJ2022-09-23
50085412722899Cycler Drainage BagBAXTER HEALTHCARE CORPORATIONKDJ2022-09-23
00085412656021MiniCapBAXTER HEALTHCARE CORPORATIONKDJ2019-07-22
50085412656026MiniCapBAXTER HEALTHCARE CORPORATIONKDJ2019-07-22
00840861102037Cycler Drain Bag SetFresenius Medical Care Holdings, Inc.KDJ2019-06-11
00085412007748MiniCapBAXTER HEALTHCARE CORPORATIONKDJ2017-12-21
50085412007743MiniCapBAXTER INTERNATIONAL INC.KDJ2017-12-21
10887488321462CARDINAL HEALTHCardinal Health 200, LLCKDJ2017-05-01
50887488321460CARDINAL HEALTHCardinal Health 200, LLCKDJ2017-05-01
00865349000308Firefly UV Disinfection DevicePURACATH MEDICAL, INCKDJ2016-11-21
00865349000315Firefly Transfer CatheterPURACATH MEDICAL, INCKDJ2016-11-21
00865349000339Firefly Luer CoverPURACATH MEDICAL, INCKDJ2016-11-21
00865349000353Firefly IPA BottlePURACATH MEDICAL, INCKDJ2016-11-21
00898021000051Alcavis 50Angelini Pharma Inc.KDJ2016-08-29
00898021000044Alcavis 50Angelini Pharma Inc.KDJ2016-08-29
20898021000055Alcavis 50ANGELINI PHARMA INC.KDJ2016-08-29
00827002089754TenckhoffCOOK INCORPORATEDKDJ2015-10-24