FDA.reportPublic FDA data

OVY by Beurer

Primary DI
00850003500560
Brand
OVY by Beurer
Company
BEURER NORTH AMERICA, L.P.
Model
OT30
Catalog number
791.77
Device description
Bluetooth Basal Thermometer with Ovy App
Published
2020-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHDDevice, Fertility Diagnostic, Proceptive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHDDevice, Fertility Diagnostic, ProceptiveUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850003500560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003500560008500035005608500035005600850003500560

Contacts#

Phone, Email table
PhoneEmail
1-800-536-0366info@beurer.com

Regulatory Flags#

DUNS number
078497467
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003500430BeurerOT20790.702019-12-09
00810110200562BeurerBR70611.142026-06-09
00850003500164BeurerFM250649.472019-06-28
00850003500041BeurerIL51 Art.- No. 619.732019-03-04
00852547004108BeurerIL50 2016-09-24
00850003500478BeurerOT80792.972021-10-01
00810110200159BeurerBM69101.352023-11-07
10810110200156BeurerBM69101.352023-11-07
00853879007515BeurerPREMIUM 800W101.732023-10-23
10853879007512BeurerPREMIUM 800W101.732023-10-23
00810110200111BeurerAuto 400101.082023-10-20
00810110200128BeurerDeluxe 600101.072023-10-20
00810110200166BeurerPREMIUM 800101.552023-10-20
00810110200210BeurerEM29642.312023-10-20
00850018808705BeurerEM 49662.782023-10-20
00850018808910BeurerBM27651.992023-10-20
10810110200118BeurerAuto 400101.082023-10-20
10810110200125BeurerDeluxe 600101.072023-10-20
10810110200163BeurerPREMIUM 800101.552023-10-20
10810110200217BeurerEM29642.312023-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09120095900793femSense FertilitySteadySense GmbHLHD2026-11-03
06430060159860Fertile WindowOuraring Inc.LHD2025-11-14
06430060159877Fertile WindowOuraring Inc.LHD2025-11-14
06430060159983Fertile WindowOuraring Inc.LHD2024-11-12
00194253312512Cycle Tracking 4.0APPLE INC.LHD2024-11-01
00194253312529Cycle Tracking 4.0APPLE INC.LHD2024-11-01
06430060159990Fertile WindowOuraring Inc.LHD2024-10-28
04260749840039Clue AppBioWink GmbHLHD2023-07-27
04260749840046Clue AppBioWink GmbHLHD2023-07-27
04260749840022Clue ConceiveBioWink GmbHLHD2023-05-14
04260749840015Clue ConceiveBioWink GmbHLHD2023-05-14
07350014630100Cycle TrackingNaturalcycles Nordic ABLHD2023-04-19
07629999054073DaysyValley Electronics AGLHD2022-12-07
07629999894334Lady-CompValley Electronics AGLHD2022-12-07
09120095900274femSense Ovulation TrackerSteadySense GmbHLHD2022-10-26
07640184680464Ava FertilityAVA Sciences-FMTC GmbHLHD2022-09-29
07640184680136Ava FertilityAVA Sciences-FMTC GmbHLHD2022-09-21
00194252845967Cycle Tracking 3.0APPLE INC.LHD2022-07-27
00194252845974Cycle Tracking 3.0APPLE INC.LHD2022-07-27
00850003500478BeurerBEURER NORTH AMERICA, L.P.LHD2021-10-01
05060508530107OvuSenseVIO HEALTHTECH LIMITEDLHD2021-07-23
05060508530114OvuSenseVIO HEALTHTECH LIMITEDLHD2021-07-23
09120095900021femSense FertilitySteadySense GmbHLHD2021-07-15
06938444982498OT80-Beurer Ovulation Predictor and Fertility Tracking KitEquinox Biotech Co., Ltd.LHD2021-06-30
09120095900014femSense KinderwunschSteadySense GmbHLHD2021-05-17
05060508530091OvuSenseVIO HEALTHTECH LIMITEDLHD2021-05-01
05060508530121OvuSenseVIO HEALTHTECH LIMITEDLHD2021-05-01
00850003500430BeurerBEURER NORTH AMERICA, L.P.LHD2019-12-09
20850003500434BeurerBEURER NORTH AMERICA, L.P.LHD2019-12-09
07290016672183Tyto DeviceTYTO CARE LTDLHD2019-01-24