FDA.reportPublic FDA data

Fast Warm-NX with Gentamicin

Primary DI
00810195241597
Brand
Fast Warm-NX with Gentamicin
Company
IRVINE SCIENTIFIC, LLC
Model
2x20ML
Catalog number
90196
Device description
Fast Warm-NX is a dual buffered solution (HEPES and MOPS) of Continuous Single Culture Medium (CSCM) containing gentamicin sulfate, 20% (v/v) Dextran Serum Supplement (DSS), and 1.0M trehalose. DSS is a protein supplement consisting of 50mg/mL therapeutic grade Human Serum Albumin (HSA) and 20 mg/mL Dextran. DSS is used at 20% (v/v) in Fast Warm-NX for a final concentration of 10mg/mL HSA and 4mg/mL Dextran. Fast Warm-NX is intended for use in assisted reproductive procedures for the thawing of vitrified human blastocyst stage embryos.
Published
2026-01-09
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
MQLMedia, Reproductive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQLMedia, ReproductiveObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250445000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250445000Fast Warm - NXFujifilm Irvine Scientific2025-09-12MQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810195241597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810195241597008101952415978101952415970810195241597

GMDN Terms#

Term, Definition table
TermDefinition
IVF mediumA solution that provides a physiological environment for the retrieval, culture, maintenance, transfer, and/or storage of human sperm, harvested oocytes (eggs), and/or resulting embryos associated with the method of in vitro fertilization (IVF). The solution typically contains various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). This is a single-use device.

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
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00810195240170Sperm Washing Medium with HSA9983-100ML99832025-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937028508LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028515LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028522LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028539LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028546LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028614LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028621LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028638LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028645LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028652LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028669LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028676LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028683LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028690LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028706LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028713LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028935LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028942LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029017LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029024LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029031LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029130LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029147LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029154LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029161LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029178LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029185LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00860012751631Warming Solution SetEXPERIMENTAL CULTURE MEDIA PRODUCTIONS AND CONSIGNMENT LLCMQL2026-04-03
00860012751648Vitrification Solution SetEXPERIMENTAL CULTURE MEDIA PRODUCTIONS AND CONSIGNMENT LLCMQL2026-04-03
00860012751655Warming Solution SetEXPERIMENTAL CULTURE MEDIA PRODUCTIONS AND CONSIGNMENT LLCMQL2026-04-03