AccessGUDID - DEVICE: Cycler Drain Bag Set (00840861102037)

GUDID

Device Identifier (DI) Information

Brand Name: Cycler Drain Bag Set
Version or Model: 026-20226A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 026-20226A
Company Name: Fresenius Medical Care Holdings, Inc.

Primary DI Number: 00840861102037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 958291411 *Terms of Use

Device Description: No description.

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
58848	Extracorporeal circuit waste bag	A flexible container intended to be used for the collection of waste fluids during preparation and processing of an extracorporeal circuit (e.g., autotransfusion, haemodialysis, haemofiltration, apheresis, adsorption treatment), including the collection and rinsing of ultrafiltrate fluid which may contain blood components. The device typically consists of a plastic pouch with a piece of short tubing and a connector (e.g., Luer-lock) intended to be connected to the tubing system of the extracorporeal circuit and possibly an outlet tap. The contents are considered potentially contaminated and should be disposed of according to local requirements. 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 [?]
K173363	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. Protect from excessive heat and freezing

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 47336087-4f6f-48ee-b110-2edef872ab2a
Public Version Date: June 02, 2023
Public Version Number: 3
DI Record Publish Date: June 11, 2019