AccessGUDID - DEVICE: Lymphostabil (07611969953073)

GUDID

Device Identifier (DI) Information

Brand Name: Lymphostabil
Version or Model: 824020
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 824020
Company Name: Bio-Rad Medical Diagnostics GmbH

Primary DI Number: 07611969953073
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 312576506 *Terms of Use

Device Description: For conservation of lymphocytes, free of Ca and Mg, not for infusion

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?
58567	Cell culture medium IVD	A liquid based tissue culture medium containing essential nutrients, sugars, amino acids and growth factors, intended to be used for the in-vitro maintenance, sustenance, and cultivation of human cells from a clinical specimen for diagnostic purposes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KIT	Media And Components, Synthetic Cell And Tissue Culture

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: less than -20 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3c490546-599b-42ef-9426-98d8d345bc83
Public Version Date: January 19, 2024
Public Version Number: 3
DI Record Publish Date: July 06, 2015