AccessGUDID - DEVICE: Plasmalink Transfer-Pack Container

GUDID

Device Identifier (DI) Information

Brand Name: Plasmalink Transfer-Pack Container - 2000 mL
Version or Model: 6R2042
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6R2042
Company Name: Fresenius Kabi AG

Primary DI Number: 00810020440669
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315654579 *Terms of Use

Device Description: For processing and/or storage of blood and blood components. 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?
44904	Blood/tissue storage/culture container	A receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK220785	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

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: 784baccc-dde4-48db-9bb5-ac653d2eeff4
Public Version Date: February 06, 2023
Public Version Number: 1
DI Record Publish Date: January 27, 2023