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Vit Kit - Thaw

EUDAMEDFDA UDI

Class III (EU MDR)

Ref 90137-DSOC

by Irvine Scientific, LLC.

Identity

Trade Name
Vit Kit - Thaw EUDAMED
Vitrification Thaw Kit (Vit Kit-Thaw) with Gentamicin and DSS FDA UDI
Generic Name
IVF medium FDA UDI
Device Name
Vitrification Thaw Kit (Vit Kit - Thaw) EUDAMED
Vitrification Thaw Kit (Vit Kit-Thaw) with Gentamicin and DSS. Includes 8x2mL Vials Thawing Solution-TS (yellow cap), 5x2mL Vials Dilution Solution-DS (orange cap) and 5x2mL Vials Washing Solution-WS (red cap). FDA UDI
Model / Reference
90137-DSOC EUDAMEDFDA UDI
Description
Vitrification Thaw Kit (Vit Kit-Thaw) with Gentamicin and DSS. Includes 8x2mL Vials Thawing Solution-TS (yellow cap), 5x2mL Vials Dilution Solution-DS (orange cap) and 5x2mL Vials Washing Solution-WS (red cap). FDA UDI

Identifiers

Catalog Number
90137-DSOC FDA UDI
Primary DI / UDI-DI
00810195240347 EUDAMEDFDA UDI
Basic UDI-DI
B-00810195240347 EUDAMED
510(k) Number
K160006 FDA UDI
FDA Product Code
MQL FDA UDI
EMDN Code
U08020501 MATERIALS/SOLUTIONS FOR FREEZING/THAWING FOR ASSISTED REPRODUCTION EUDAMED
GMDN Term
IVF medium FDA UDI

Classification

Device Class
Class III EUDAMED
Class II FDA UDI
Regulation Number
884.6180 FDA UDI
Market of Registration
Netherlands EUDAMED
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

Yes

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

Yes

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Vit Kit - Thaw by Irvine Scientific, Llc — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Irvine Scientific, LLC.
EUDAMED SRN
US-MF-000007514
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (3)

  • EUDAMED f8413789-9926-4898-a19a-da3ad03d9300 61 fields · synced Jul 14, 2026
  • FDA UDI 9afb0b23-5075-406d-8b71-f28f37ef8296 36 fields · synced May 30, 2026
  • EUDAMED f3d7ed7d-ae64-4a36-8282-3bb1f77818f4 61 fields · synced Jul 14, 2026