AccessGUDID - DEVICE: Cycler Drainage Bag (00085412007410)

GUDID

Device Identifier (DI) Information

Brand Name: Cycler Drainage Bag
Version or Model: 5C4145P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5C4145P
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 00085412007410
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 005146311 *Terms of Use

Device Description: This product is to be used with Baxter APD Sets with Cassette. Baxter Manifold Sets and Extension Sets may also be used. Consult instructions for use.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35000	Peritoneal dialysis system tubing set	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDJ	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K791899	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 15 Liter

Device Record Status

Public Device Record Key: 6f94c06a-3081-4e4c-8daf-56c3f542f63e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015