Natural Cycles

Primary DI
07350014630131
Brand
Natural Cycles
Company
Naturalcycles Nordic AB
Model
13
Device description
Package for 6-month subscription of Natural Cycles. Includes a Basal Body Thermometer and a subscription code for 6 months access to the app.
Published
2019-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN170052000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170052000Natural CyclesNatural Cycles Nordic AB2018-08-10PYT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350014630131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350014630131073500146301317350014630131

GMDN Terms#

Term, Definition table
TermDefinition
Self-care monitoring/reporting softwareAn application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.

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
07350014630285Natural Cycles ApplicationV5.02021-11-12
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

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
07350014630285Natural Cycles ApplicationNaturalcycles Nordic ABPYT2021-11-12
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