FDA.reportPublic FDA data

Cycler Drainage Bag

Primary DI
50085412722899
Brand
Cycler Drainage Bag
Company
BAXTER HEALTHCARE CORPORATION
Model
5C4145NS
Catalog number
5C4145NS
Device description
The 15L Cycler Drainage Bag is not sterile product and is intended to serve as a container or device to collect (effluent) peritoneal cavity drainage from the drain line on Baxter Automated Peritoneal Dialysis (APD) Cycler Tubing Sets.
Published
2022-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K214016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K21401600015L Cycler Drainage BagBaxter Healthcare Corporation2022-03-18KDJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50085412722899PackageGS130In Commercial Distribution
00085412722894PrimaryGS10
70085412722893Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541272289950085412722899
00085412722894000854127228940854127228940085412722894
7008541272289370085412722893

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume15Liter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room Temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)422-9837MEDINFO_MEDPRODUCTS@baxter.com

Regulatory Flags#

DUNS number
005083209
Device count
2
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412036373INTERLINK2C75572C75572016-09-24
00085412036380INTERLINK2C75582C75582016-09-24
00085412046372CLEARLINK2C88572C88572016-09-24
00085412071688CLEARLINK2C88582C88582016-09-24
00085412003252Aviva/Viaflex2B80662B80662016-09-24
00085412036311Baxter2C62502C62502016-09-24
00085412600024DUPLOCATH150616515061652018-09-28
00085412600031DUPLOCATH150616615061662018-09-28
00085412600048DUPLOCATH150616715061672018-09-28
00085412002576INTERLINK2C74512C74512016-09-24
00085412002583INTERLINK/DUO-VENT2C74522C74522016-09-24
00085412004976INTERLINK2N33952N33952016-09-24
00085412046334CLEARLINK2C86712C86712016-09-24
00085412046433CLEARLINK2H86032H86032016-09-24
00085412048963CLEARLINK2C86102C86102016-09-24
00085412049007CLEARLINK2C86322C86322016-09-24
00085412049014CLEARLINK2C86062C86062016-09-24
00085412051727CLEARLINK1C86931C86932016-09-24
00085412070056CLEARLINK2C86122C86122016-09-24
00085412071671CLEARLINK2C86072C86072016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332414208059Extension Set with EASY-LOCK ConnectorVantive US Healthcare LLCKDJ2026-10-07
07332414208028MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra ShortVantive US Healthcare LLCKDJ2026-07-22
07332414254551MINICAP EXTENDED LIFE PD TRANSFER SET WITH TWISTVantive US Healthcare LLCKDJ2026-07-06
07332414208417MANIFOLD SETVantive US Healthcare LLCKDJ2026-06-22
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
08964004471018Automated PD Set DS-1BYONYKS PRIVATE LIMITEDKDJ2025-09-08
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
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