AccessGUDID - DEVICE: VersiPD (00840861102211)

GUDID

Device Identifier (DI) Information

Brand Name: VersiPD
Version or Model: 050-87225
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Fresenius Medical Care Holdings, Inc.

Primary DI Number: 00840861102211
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 958291411 *Terms of Use

Device Description: Disposable Set - 20 ft patient line, 20 ft drain line, 3 solution lines, 1 stay-safe PIN connector

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 [?]
K212522	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
Storage Environment Temperature: between 0 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a5630695-2a33-4994-b668-b401a20ed9b9
Public Version Date: February 22, 2023
Public Version Number: 1
DI Record Publish Date: February 14, 2023