AccessGUDID - DEVICE: AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS Spike (00810020440270)

GUDID

Device Identifier (DI) Information

Brand Name: AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS Spike
Version or Model: 4R2358
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4R2358
Company Name: Fresenius Kabi AG

Primary DI Number: 00810020440270
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315654579 *Terms of Use

Device Description: For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator.

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?
47572	Apheresis system tubing set	A collection of sterile, flexible, plastic tube segments and associated items (e.g., connectors, line clamp, drip chamber) intended to be used in an apheresis system to channel blood from the patient to an appropriate apheresis column before being returned to the patient. It creates a closed-circuit for the extracorporeal removal of a constituent of whole blood (e.g., leukocytes, plasma). The channeling of apheresis solutions for the priming, regeneration, preservation of columns before or after an apheresis procedure may also be through the tubing set. 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 [?]
BK230824	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: The storage range for this kit is 0°C (32°F) – 40°C (104°F), however it is recommended to be stored at Room Temperature.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0a50cea9-00d8-4e11-be46-eafc28283918
Public Version Date: May 30, 2023
Public Version Number: 1
DI Record Publish Date: May 22, 2023