FDA.reportPublic FDA data

Natural Cycles Application

Primary DI
07350014630285
Brand
Natural Cycles Application
Company
Naturalcycles Nordic AB
Model
V5.0
Published
2021-11-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Product Codes#

Code, Name table
CodeName
PYTDevice, Fertility Diagnostic, Contraceptive, Software Application

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYTDevice, Fertility Diagnostic, Contraceptive, Software ApplicationObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350014630285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350014630285073500146302857350014630285

GMDN Terms#

Term, Definition table
TermDefinition
Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of luteinizing hormone (LH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
352550104
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350014630346Natural Cycles0342026-02-27
07350014630353Natural Cycles0352026-02-27
07350014630360Natural Cycles0362026-02-27
07350014630339Natural Cycles ApplicationV5.4.02025-05-02
07350014630155Natural Cycles152019-09-01
04719003114114Natural CyclesMT16W2NCTG22024-09-18
07350014630100Cycle Tracking1.0.0.0022023-04-19
17350014630152Natural Cycles Pregnancy TestsW001011232023-05-14
07350014630209Natural Cycles202020-02-09
17350014630145Natural Cycles Ovulation TestsW002103292023-05-14
07350014630148Natural Cycles142019-09-01
07350014630124Natural CyclesB2019-03-04
07350014630131Natural Cycles132019-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350014630346Natural CyclesNaturalcycles Nordic ABPYT2026-02-27
07350014630353Natural CyclesNaturalcycles Nordic ABPYT2026-02-27
07350014630360Natural CyclesNaturalcycles Nordic ABPYT2026-02-27
07350014630339Natural Cycles ApplicationNaturalcycles Nordic ABPYT2025-05-02
04260749840008Clue Birth ControlBioWink GmbHPYT2022-04-08
B441SMANDCLIENTAPP0Spaulding Client AppSPAULDING MEDICAL, LLCPYT2020-04-02
B441SMIOSCLIENTAPP0Spaulding Client AppSPAULDING MEDICAL, LLCPYT2020-04-02
B441SMWINCLIENTAPP0Spaulding Client AppSPAULDING MEDICAL, LLCPYT2020-04-02
07350014630209Natural CyclesNaturalcycles Nordic ABPYT2020-02-09
07350014630124Natural CyclesNaturalcycles Nordic ABPYT2019-03-04
07350014630131Natural CyclesNaturalcycles Nordic ABPYT2019-02-28