AccessGUDID - DEVICE: Plastic Storage Container (04086000100175)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 04086000100175
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315654579 *Terms of Use

Device Description: 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

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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
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.

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK990009	0

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

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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.

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0cf629eb-f232-40c5-b95c-dfae90dc585b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 02, 2016