FDA.report

DMEM (1X) Dulbecco's Modified Eagle Medium

Primary DI
30190302000547
Brand
DMEM (1X) Dulbecco's Modified Eagle Medium
Company
LIFE TECHNOLOGIES CORPORATION
Model
11960044
Published
2016-08-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Product Codes

CodeName
NDSMEDIA, CULTURE, EX VIVO, TISSUE AND CELL

Product Code Classifications

CodeDeviceSpecialtyClass
NDSMedia, Culture, Ex Vivo, Tissue And CellGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30190302000547PackageGS110Not in Commercial Distribution
50190302000541PackageGS110Not in Commercial Distribution
10190302000543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3019030200054730190302000547
5019030200054150190302000541
1019030200054310190302000543

GMDN Terms

TermDefinition
Cell culture medium IVDA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
118793157
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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