Cycler Drainage Bag 5C4145NS

GUDID 50085412722899

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.

BAXTER HEALTHCARE CORPORATION

Peritoneal dialysis system tubing set
Primary Device ID50085412722899
NIH Device Record Key3606a169-9de4-49f6-b267-938ad46876f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameCycler Drainage Bag
Version Model Number5C4145NS
Catalog Number5C4145NS
Company DUNS005083209
Company NameBAXTER HEALTHCARE CORPORATION
Device Count2
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com
Phone+1(800)422-9837
EmailMEDINFO_MEDPRODUCTS@baxter.com

Device Dimensions

Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter
Total Volume15 Liter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room Temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100085412722894 [Primary]
GS150085412722899 [Package]
Contains: 00085412722894
Package: CA [30 Units]
In Commercial Distribution
GS170085412722893 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDJSet, Administration, For Peritoneal Dialysis, Disposable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-03
Device Publish Date2022-09-23

Devices Manufactured by BAXTER HEALTHCARE CORPORATION

05413765852428 - Novum IQ2024-09-23 The Novum IQ Syringe Pump is software controlled Syringe infusion pump system that provides delivery of fluids into a patient
20085412676610 - DOSE IQ SAFETY SOFTWARE2024-09-02 Infusion Safety Management Software
20085412841629 - MINICAP EXTENDED LIFE PD TRNS2024-08-13 This set consists of a female locking connector/on-off clamp assembly, tubing and double sealing male Luer lock connector. This
50197886004354 - CLEARLINK/CONTINU-FLO2024-06-10 QuickStay Set, 24 Hour Max Use, For Gravity Use Only, Clearlink System, Non-DEHP Continu-Flo Solution Set with Duo-Vent Spike, 1
50197886004361 - CLEARLINK/CONTINU-FLO2024-06-10 QuickStay Set, 24 Hour Max Use, For Gravity Use Only, Clearlink System, Non-DEHP Continu-Flo Solution Set with Duo-Vent Spike, 9
10085412676613 - DOSE IQ SAFETY SOFTWARE2024-04-30 Infusion Safety Management Software
05413765851797 - Novum IQ2024-04-18 The Novum IQ Large Volume Pump (LVP) is a large volume infusion pump system that provides delivery of fluids into a patient in a
51978860004350 - CLEARLINK/CONTINU-FLO2024-04-04 QuickStay Set, 24 Hour Max Use, For Gravity Use Only, Clearlink System, Non-DEHP Continu-Flo Solution Set with Duo-Vent Spike, 1

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.