AccessGUDID - DEVICE: Fenwal AMICUS RBC Set w/SEPACELL R-3000 RBC Leukocyte Reduction Filter (M5264C23041)

GUDID

Device Identifier (DI) Information

Brand Name: Fenwal AMICUS RBC Set w/SEPACELL R-3000 RBC Leukocyte Reduction Filter
Version or Model: 4C2304
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4C2304
Company Name: Fresenius Kabi AG

Primary DI Number: M5264C23041
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 315654579 *Terms of Use

Device Description: For Filtration and Storage of One Unit of ACD-A/ADSOL Red Blood Cells. 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
GKT	Separator, Automated, Blood Cell, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK000039	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

[?]

Storage and Handling
Special Storage Condition, Specify: Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ef6f0186-371b-4ded-a6a9-1388d38cbb87
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 18, 2017