FDA.reportPublic FDA data

CHANG Medium B

Primary DI
00810195240606
Brand
CHANG Medium B
Company
IRVINE SCIENTIFIC, LLC
Model
C100-90ML
Catalog number
C100
Device description
CHANG Medium Basal. 90mL bottle.
Published
2025-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
KITMedia And Components, Synthetic Cell And Tissue Culture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KITMedia And Components, Synthetic Cell And Tissue CultureHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810195240606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810195240606008101952406068101952406060810195240606

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
121584789
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810195241597Fast Warm-NX with Gentamicin2x20ML901962026-01-09
00810195241603Fast Warm-NX with Gentamicin6x2ML901962026-01-09
00810195240477Continuous Single Culture Complete (CSCM-C) with Gentamicin and HSA 90165-2x20ML901652025-06-02
00810195240002cryo-GO Vitrification Device - Red (Pack of 10)70307-R70307-R2025-06-02
00810195240019cryo-GO Vitrification Device - Yellow (Pack of 10)70308-Y70308-Y2025-06-02
00810195240026cryo-GO Vitrification Device - Blue (Pack of 10)70309-B70309-B2025-06-02
00810195240033cryo-GO Vitrification Device - Green (Pack of 10)70310-G70310-G2025-06-02
00810195240040cryo-GO Vitrification Device - Purple (Pack of 10)70311-P70311-P2025-06-02
00810195240057cryo-GO Vitrification Device - Red (Pack of 50)70312-R70312-R2025-06-02
00810195240064cryo-GO Vitrification Device - Yellow (Pack of 50)70313-Y70313-Y2025-06-02
00810195240071cryo-GO Vitrification Device - Blue (Pack of 50)70314-B70314-B2025-06-02
00810195240088cryo-GO Vitrification Device - Green (Pack of 50)70315-G70315-G2025-06-02
00810195240095cryo-GO Vitrification Device - Purple (Pack of 50)70316-P70316-P2025-06-02
00810195240101SSS-NX (Serum Substitute Supplement - NX)90194-100ML901942025-06-02
00810195240118SSS-NX (Serum Substitute Supplement - NX)90194-12x10ML901942025-06-02
008101952401257% PVP Solution with HSA90121-5x0.5ML901212025-06-02
0081019524013210% PVP Solution with HSA90123-5x0.5ML901232025-06-02
00810195240149Arctic Sperm Cryopreservation Medium90170-12x5ML901702025-06-02
00810195240156Refrigeration Medium - Test Yolk Buffer (TYB) with Gentamicin90129-20x5ML901292025-06-02
00810195240163Freezing Medium Test Yolk Buffer (TYB) with Glycerol and Gentamicin90128-20x5ML901282025-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840075404729TheraPEAK X-VIVO™ 15 without Gentamicin or Phenol RedLonza Walkersville, Inc.KIT2026-05-27
10190302001236Minimum Essential Medium (MEM) (1X)LIFE TECHNOLOGIES LIMITEDKIT2023-10-02
10190302003650Dulbeccos Modified Eagle MediumLIFE TECHNOLOGIES LIMITEDKIT2023-10-02
10190302004459BME, Basal Medium (Eagle) (1X)LIFE TECHNOLOGIES LIMITEDKIT2023-10-02
10190302004718Minimum Essential Medium (MEM) (1X)LIFE TECHNOLOGIES LIMITEDKIT2023-10-02
00840075400141X-VIVO 10 w/o Gent,PR&w/ RecTrnsfrn 50LLonza Walkersville, Inc.KIT2022-12-08
00840075400202STD ProCHO 5 Powder, 500 LLonza Walkersville, Inc.KIT2022-12-08
00840075400233RoosterBasal(TM)-MSC-CC, 500mlLonza Walkersville, Inc.KIT2022-12-08
00840075400264Insect-XPRESS w/ L-Gln 1 LLonza Walkersville, Inc.KIT2022-12-08
00840075400301TheraPEAK™ SfAAV™ 1L bottleLonza Walkersville, Inc.KIT2022-12-08
00840075400349VEGGIE 10 MEDIUM WITH ADDITIVES, 200LLonza Walkersville, Inc.KIT2022-12-08
00840075400356TheraPEAK™ X-VIVO™ 15 w/o Gent or PR, 1LLonza Walkersville, Inc.KIT2022-12-08
00840075400363Solution E LifeCell p/n 131P0063, lL botLonza Walkersville, Inc.KIT2022-12-08
00840075400370TheraPEAK™ Lymphocyte Separation MediumLonza Walkersville, Inc.KIT2022-12-08
00840075400493UltraCULTURE, 200L bagLonza Walkersville, Inc.KIT2022-12-08
00840075400653TheraPEAK™ X-VIVO™ 15 w/o Gent or PR, 5LLonza Walkersville, Inc.KIT2022-12-08
00840075400677HAL-MEM WITH LAH #00-0704-00, 200L bagLonza Walkersville, Inc.KIT2022-12-08
00840075400936Solution E LifeCell 131P0077-02, 100L drLonza Walkersville, Inc.KIT2022-12-08
00840075400981RPMI1640 4.5g/L GLUC,NAHCO3,W/O GLUT,50LLonza Walkersville, Inc.KIT2022-12-08
00840075400998TheraPEAK ACK Lysing Buffer (1x), 100mLLonza Walkersville, Inc.KIT2022-12-08
00840075401049RPMI 1640 W/GLUT. & GENTAM., 500 ml botLonza Walkersville, Inc.KIT2022-12-08
00840075401100Dulbecco's (PBS) w/o Ca and Mg, lL botLonza Walkersville, Inc.KIT2022-12-08
00840075401179SOLUTION Z LIFECELL P/N 131P0120, 75LLonza Walkersville, Inc.KIT2022-12-08
008400754012234Cell Insect CD Medium, 1LLonza Walkersville, Inc.KIT2022-12-08
00840075401292STD PowerCHO Advance 100 LLonza Walkersville, Inc.KIT2022-12-08
00840075401414ProCHO 5 serum-free media 1 LLonza Walkersville, Inc.KIT2022-12-08
00840075401476STD PowerCHO Advance 10LLonza Walkersville, Inc.KIT2022-12-08
00840075401483Solution Z LifeCell P/N 131P0115, 1LLonza Walkersville, Inc.KIT2022-12-08
00840075401544STD PowerCHO-2w/oPEG,InsProlpCit2777.8gLonza Walkersville, Inc.KIT2022-12-08
00840075401629ProCHO 4 w/o Phenol Red, 1 LLonza Walkersville, Inc.KIT2022-12-08