AccessGUDID - DEVICE: Empty Sterile Container (00085412007670)

GUDID

Device Identifier (DI) Information

Brand Name: Empty Sterile Container
Version or Model: 5C4462
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5C4462
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 00085412007670
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005146311 *Terms of Use

Device Description: This set is intended for use with a Baxter transfer set for peritoneal dialysis patients requiring a sterile container for drainage. (i.e. CCPD patients doing a daytime exchange or CAPD patients who have disconnected between exchanges).

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
FKX	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K833065	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: 3 Liter

Device Record Status

Public Device Record Key: f8ceba36-7420-40d7-acc6-0c752d0a31b1
Public Version Date: July 21, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2015