FDA.reportPublic FDA data

cryo-GO Vitrification Device - Red (Pack of 10)

Primary DI
00810195240002
Brand
cryo-GO Vitrification Device - Red (Pack of 10)
Company
IRVINE SCIENTIFIC, LLC
Model
70307-R
Catalog number
70307-R
Device description
cryo-GO Vitrification Device - Red (Pack of 10). A device composed of a body and a cap for use in ART procedures which includes oocytes and embryoscryopreservation by vitrification. The device is to be used with a vitrification and warming protocol.
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
Single use
true

Product Codes#

Code, Name table
CodeName
MQKLabware, Assisted Reproduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQKLabware, Assisted ReproductionObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810195240002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810195240002008101952400028101952400020810195240002

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction vitrification carrierA sterile, plastic device used during an assisted reproduction vitrification (cryopreservation) procedure to hold a small volume of vitrification media containing a biological specimen (e.g., egg, embryo) to vitrify (cryopreserve) the specimen, thereby avoiding specimen immersion/contact with LN2. The vitrification process may involve the distal tip/specimen being brought into contact with the surface of a vitrification block [a highly-conductive mass of metal semi-submersed in a liquid nitrogen (LN2) bath]. The device with vitrified specimen is then stored in an LN2 tank, and subsequently transferred into a warming medium to recover the specimen. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
121584789
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
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
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

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00810195240019cryo-GO Vitrification Device - Yellow (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240026cryo-GO Vitrification Device - Blue (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02
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