AccessGUDID - DEVICE: Lympholyte-H (00628451099499)

GUDID

Device Identifier (DI) Information

Brand Name: Lympholyte-H
Version or Model: CL5026
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CL5026
Company Name: Cedarlane Corporation

Primary DI Number: 00628451099499
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243928822 *Terms of Use
Previous DI: 06284510990493

Device Description: Lympholyte-H Cell Separation Media (Isolation of lymphocytes from Human peripheral blood), liquid

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):	No
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?
41427	Cell centrifugation/density gradient separation reagent IVD	A substance or reactant intended to be used for the isolation of cells from a clinical specimen (e.g., lymphocytes from whole blood, cells from a liquid-based cytology specimen) using centrifugation and density gradient to achieve specimen component separation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JCF	Lymphocyte Separation Medium

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 3 Liter

Device Record Status

Public Device Record Key: 6e032a7d-09b7-444a-8a4d-3f9287b24650
Public Version Date: December 18, 2024
Public Version Number: 1
DI Record Publish Date: December 10, 2024