FDA.reportPublic FDA data

ZyMot

Primary DI
10860451001257
Brand
ZyMot
Company
DXNOW, INC.
Model
Multi 3mL
Catalog number
ZPH1300
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
10860451001257PrimaryGS10
00860451001250Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086045100125710860451001257
00860451001250008604510012508604510012500860451001250

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction microtoolA dedicated pipette or other device used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. This is a single-use device.

Regulatory Flags#

DUNS number
078815798
Device count
3
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
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
Primary DIBrandCompanyProduct codePublished
00888937029048LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
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
B056CLRCTLG1CRYOLOCK(LG)BIOTECH INCORPORATEDMQK2025-12-08
B056SCLLG1S-CRYOLOCK(LG)BIOTECH INCORPORATEDMQK2025-12-08
B056CLRCTLG2CRYOLOCK(LG)BIOTECH INCORPORATEDMQK2025-12-08
B056SCLLG2S-CRYOLOCK(LG)BIOTECH INCORPORATEDMQK2025-12-08
B056CLRCTPK1CRYOLOCK(PK)BIOTECH INCORPORATEDMQK2025-10-27
B056CLRCTPR1CRYOLOCK(PR)BIOTECH INCORPORATEDMQK2025-10-27
B056SCLPK1S-CRYOLOCK (PK)BIOTECH INCORPORATEDMQK2025-10-27
B056SCLPR1S-CRYOLOCK (PR)BIOTECH INCORPORATEDMQK2025-10-27
20888937025860PICSI®Coopersurgical, Inc.MQK2025-10-20
06975183900017Hariomed culture dishHua Yue Medical Technology Co., Ltd.MQK2025-09-30
06975183900185Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd.MQK2025-09-30
06975183900192Time-lapse Incubator Capacity Expansion ModuleHua Yue Medical Technology Co., Ltd.MQK2025-09-30
06975183900208Hariomed humidification boxHua Yue Medical Technology Co., Ltd.MQK2025-09-30
00810195240002cryo-GO Vitrification Device - Red (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02
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