FDA.reportPublic FDA data

ZyMot

Primary DI
00860004123934
Brand
ZyMot
Company
DXNOW, INC.
Model
Multi 3mL
Catalog number
ZMH3000
Device description
Sperm Separation Device Natech 3mL 10 pack
Published
2021-08-16
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
00860004123934PrimaryGS10
00860004123958Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860004123934008600041239348600041239340860004123934
00860004123958008600041239588600041239580860004123958

Sterilization Methods#

Method table
Method

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
00860004123941ZyMotMulti 3mLZPH13002021-08-16
10860004123900ZyMotMulti 850 microLZPH18502021-02-25
10860451001233ZyMotICSIZPH10022021-02-25
10860451001240ZyMotMulti 850 microLZPH18502021-02-25
10860451001257ZyMotMulti 3mLZPH13002021-02-25
00860004123910ZyMotMulti 850 microLZMH08502021-02-25
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
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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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20888937025860PICSI®Coopersurgical, Inc.MQK2025-10-20
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