AccessGUDID - DEVICE: DMEM (Dulbecco's Modified Eagle Medium) (10190302002035)

GUDID

Device Identifier (DI) Information

Brand Name: DMEM (Dulbecco's Modified Eagle Medium)
Version or Model: 11885076
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: LIFE TECHNOLOGIES CORPORATION

Primary DI Number: 10190302002035
Issuing Agency: GS1
Commercial Distribution End Date: April 29, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 118793157 *Terms of Use

Device Description: No description.

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:	No
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?
62068	Ex vivo cell culture medium	A solution used for the ex-vivo culture of human-derived or non-human cells [e.g., T-lymphocytes, mesenchymal stem cells (MSCs), embryonic stem cells, induced pluripotent stem cells (iPSC)] or immortalised cell lines (e.g., HaCat, HeLa, HEK-293, cos-7, PC-12) intended for cell therapy applications. The solution contains a combination of nutrients, which may include amino acids, vitamins and organic salts that are vital for the growth and maintenance of the cell type/line. It is not intended for in vitro fertilization (IVF) or in vitro diagnostic applications.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDS	MEDIA, CULTURE, EX VIVO, TISSUE AND CELL

FDA Premarket Submission

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

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: 4f5f7d9c-d4a5-4781-9c74-4ecf42337f10
Public Version Date: May 09, 2022
Public Version Number: 6
DI Record Publish Date: August 01, 2016