FDA.reportPublic FDA data

SSS-NX (Serum Substitute Supplement-NX)

Primary DI
00857515006634
Brand
SSS-NX (Serum Substitute Supplement-NX)
Company
FUJIFILM IRVINE SCIENTIFIC, INC.
Model
90194 100 mL
Catalog number
90194
Device description
SSS-NX (Serum Substitute Supplement-NX) consists of human serum albumin and human serum globulins in saline solution and is intended for use in assisted reproductive procedures which include gamete and embryo manipulation and culture. These procedures include the use of SSS-NX as a supplement for culture medium.
Published
2024-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K233764000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233764000SSS-NX (Serum Substitute Supplement-NX)Fujifilm Irvine Scientific2024-04-24MQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857515006634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857515006634008575150066348575150066340857515006634

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
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8004375706tmrequest@irvinesci.com

Regulatory Flags#

DUNS number
057475246
Device count
1
Combination product
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00893727002200Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin90128-100mL901282016-09-10
00893727002361ISolate®99264-2x50mL992642016-09-10
00893727002903Human Serum Albumin Solution9988-100mL99882016-09-10
00893727002002Oil for Embryo Culture9305-100mL93052016-09-10
00893727002019PBS 1X - Dulbecco's Phosphate Buffered Saline Solution9235-500mL92352016-09-10
00893727002071Sperm Washing Medium9983-100mL99832016-09-10
00893727002088Sperm Washing Medium9983-12X12mL99832016-09-10
00893727002101Human Serum Albumin Solution9988-12X5mL99882016-09-10
00893727002125Hyaluronidase Solution90101-5X1mL901012016-09-10
008937270021637% PVP Solution with HSA90121-5X0.5mL901212016-09-10
0089372700217010% PVP Solution with HSA90123-5X0.5mL901232016-09-10
00893727002217Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin90128-20X5mL901282016-09-10
00893727002354ISolate®99264-12X6mL992642016-09-10
00893727002378ISolate® Concentrate99306-100ml993062016-09-10
00893727002781Oil for Embryo Culture9305-500mL93052016-09-10
00893727002859ISolate® Stock Solution99275-100ML992752016-09-10
00893727002194Modified HTF Medium-HEPES with Gentamicin90126-100mL901262016-09-10
00893727002804HTF Medium with Gentamicin90125-100mL901252016-09-10
00893727002910HTF Medium with Gentamicin90125-500mL901252016-09-10
00893727002927Modified HTF Medium-HEPES with Gentamicin90126-500mL901262016-09-10

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