FDA.reportPublic FDA data

ZyMot

Primary DI
00860004123910
Brand
ZyMot
Company
DXNOW, INC.
Model
Multi 850 microL
Catalog number
ZMH0850
Device description
Sperm Separation Device
Published
2021-02-25
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173075000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173075000ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)Dxnow, Inc.2018-03-08MQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860004123910PrimaryGS10
00860004123903Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860004123910008600041239108600041239100860004123910
00860004123903008600041239038600041239030860004123903

Regulatory Flags#

DUNS number
078815798
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860004123934ZyMotMulti 3mLZMH30002021-08-16
00860004123941ZyMotMulti 3mLZPH13002021-08-16
10860004123900ZyMotMulti 850 microLZPH18502021-02-25
10860451001233ZyMotICSIZPH10022021-02-25
10860451001240ZyMotMulti 850 microLZPH18502021-02-25
10860451001257ZyMotMulti 3mLZPH13002021-02-25
00860451001205ZyMotICSIZIH00022021-02-25
00860451001212ZyMotMulti 850 microLZMH08502021-02-25
00860451001229ZyMotMulti 3mLZMH30002021-02-25
00860004123903ZyMotMulti 850 microLZPH18502021-02-25
00860451001236ZyMotICSIZPH10022021-02-25
00860451001243ZyMotMulti 850 microLZPH18502021-02-25
00860451001250ZyMotMulti 3mLZPH13002021-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00843277100109SwimCount® HarvesterMotilitycount ApSMQK2026-07-07
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00888937029055LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029062LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029079LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029086LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029093LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029109LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
06971855770308Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770315Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770322Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770339Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770377Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
00888937027945ZyMotCoopersurgical, Inc.MQK2026-01-23
00888937027952ZyMotCoopersurgical, Inc.MQK2026-01-23
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B056SCLPK1S-CRYOLOCK (PK)BIOTECH INCORPORATEDMQK2025-10-27
B056SCLPR1S-CRYOLOCK (PR)BIOTECH INCORPORATEDMQK2025-10-27
20888937025860PICSI®Coopersurgical, Inc.MQK2025-10-20
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06975183900208Hariomed humidification boxHua Yue Medical Technology Co., Ltd.MQK2025-09-30
00810195240002cryo-GO Vitrification Device - Red (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02