AccessGUDID - DEVICE: Leukoconnect (00811137010486)

GUDID

Device Identifier (DI) Information

Brand Name: Leukoconnect
Version or Model: 4C4300
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4C4300
Company Name: FENWAL, INC.

Primary DI Number: 00811137010486
Issuing Agency: GS1
Commercial Distribution End Date: April 28, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 794519020 *Terms of Use

Device Description: LEUKOCONNECT Pre-Storage Sterile Connect Leukoreduction Set with SEPACELL RS-2000 Filter for Red Blood Cells in Additive Solution. 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?
38569	Blood transfusion set, non-exchange	An intravascular administration set intended to be used to administer blood from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAK	Microfilter, Blood Transfusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK020008	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7588a700-5444-440d-a154-c078c4e16bd5
Public Version Date: April 21, 2023
Public Version Number: 5
DI Record Publish Date: September 12, 2016