AccessGUDID - DEVICE: Plastic Storage Container (04086000100175)

GUDID

Brand Name: Plastic Storage Container
Version or Model: X6R2350
Catalog Number: X6R2350
Company Name: Fresenius Kabi AG

Primary DI Number: 04086000100175
Issuing Agency: GS1
Device Count: 1

Device Description: Sterile Fluid Path.

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

GMDN Preferred Term Name	GMDN Definition
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.

Product Code	Product Code Name
GKT	Separator, Automated, Blood Cell, Diagnostic

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling
Special Storage Condition, Specify: Product Should be Handled and Stored according to Guidelines for the Component Collected. Store at Room Temperature. Protect from freezing. Avoid excessive heat.

Size Type Text
No Device Sizes

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 02, 2016
Commercial Distribution End Date:

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
24086000100179	7	14086000100172		In Commercial Distribution	Carton
14086000100172	4	04086000100175		In Commercial Distribution	Inner Pack

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Device Subject to Direct Marking (DM), but Exempt: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

No Customer Contact currently defined