AccessGUDID - DEVICE: Effluent Sample Bag (00085412007717)

GUDID

Device Identifier (DI) Information

Brand Name: Effluent Sample Bag
Version or Model: 5C4476
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5C4476
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 00085412007717
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005146311 *Terms of Use

Device Description: This bag is intended to collect sample drainage of peritoneal dialysis effluent from Baxter Peritoneal Dialysis Tubing Sets and is intended for use with Luer connector products.

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

FDA Product Code

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Product Code	Product Code Name
FKX	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K923065	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

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e4faaf8b-3b92-4870-9a36-0156a0e55fb1
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015