AccessGUDID - DEVICE: Waste Transfer Set (04052682031724)

GUDID

Device Identifier (DI) Information

Brand Name: Waste Transfer Set
Version or Model: X6C2172
Commercial Distribution Status: In Commercial Distribution
Catalog Number: X6C2172
Company Name: Fresenius Kabi AG

Primary DI Number: 04052682031724
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315654579 *Terms of Use

Device Description: For Red Blood Cell Exchange (RBCX) Procedures. For use with the AMICUS Separator. Sterile Fluid Path.

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):	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?
44903	Blood transfer set	A collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180615	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 freezing. Avoid excessive heat.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0c40972d-bb1c-4e11-9bfc-e56bc3a6cd6e
Public Version Date: March 11, 2019
Public Version Number: 1
DI Record Publish Date: February 20, 2019