INTERGRATED APD SET - This integrated automated PD Set is compatible - BAXTER INTERNATIONAL INC.

Duns Number:005146311

Device Description: This integrated automated PD Set is compatible with Baxter Automated PD systems, Baxter PD This integrated automated PD Set is compatible with Baxter Automated PD systems, Baxter PD Transfer Sets and Effluent Sample Bag. Integrated APD set with Cassette 3-Prong

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More Product Details

Catalog Number

L5C4531

Brand Name

INTERGRATED APD SET

Version/Model Number

L5C4531

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K102936,K102936

Product Code Details

Product Code

FKX

Product Code Name

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Device Record Status

Public Device Record Key

e0faee20-9321-4141-ab61-f68e2e92432f

Public Version Date

October 11, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

50085412090073

Quantity per Package

30

Contains DI Package

00085412090078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"BAXTER INTERNATIONAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 358