Beurer 792.97

GUDID 00850003500478

Beurer Fertility Convenience Kit with Pearl App Each kit contains: 15 FSH test strips, 15 LH test strips, 2 hCG test strips (pregnancy test), Access (activation code) for the Pearl Fertility App.

BEURER NORTH AMERICA, L.P.

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00850003500478
• NIH Device Record Key: 0eb3364c-02e7-4473-b482-c791821499c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beurer
• Version Model Number: OT80
• Catalog Number: 792.97
• Company DUNS: 078497467
• Company Name: BEURER NORTH AMERICA, L.P.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003500478 [Primary]
GS1	10850003500475 [Package]; Package: Inner Case [12 Units]; In Commercial Distribution
GS1	20850003500472 [Package]; Contains: 10850003500475; Package: Case [4 Units]; In Commercial Distribution

FDA Product Code

• LHD: Device, Fertility Diagnostic, Proceptive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-11
• Device Publish Date: 2021-10-01

On-Brand Devices [Beurer]

• 10736211162219: Glass Body Analysis Scale
• 10736211161915: XL Cuff (33-43 cm) for use with Blood Pressure Monitor Model # BM35 (Type BM35/1)
• 10853879007994: Massager
• 20853879007939: Lice Comb (Powered)
• 10853879007758: Body Fat Scale
• 10853879007505: Body Fat Scale
• 10853879007338: Tens Device Knee / Elbow 2 in 1 For the temporary relief of pain associated with sore and aching
• 10853879007321: Electric dual breast pump
• 20853879007304: Replacement Electrodes Set for use with EM44 Beurer TENS Device (Art.- No. 642.71)
• 20853879007281: Digital TENS Device
• 10853879007116: Bluetooth® Pulse Oximeter for wellnessuse
• 10853879007079: Wrist Bluetooth® Blood Pressure Monitor
• 10853879007062: BF70 Bluetooth® Diagnostic Scale
• 10853879007055: BM67 Bluetooth® Upper Arm Blood Pressure Monitor * with standard cuff 8.7 - 14.2 in (22 - 36 cm
• 00853879007027: Wearable air-conduction hearing aid - wearable sound-amplifying device that is intended to compe
• 10852547004921: Glass Body Analysis Scale
• 10852547004839: Fascia Massager
• 10852547004730: Light based, over the counter device intended for the removal of unwanted hair as well as perman
• 20852547004713: IR Ear Thermometer
• 10852547004709: Upper Arm Blood Pressure Monitor
• 20852547004690: Wrist Blood Pressure Monitor
• 20852547004645: Wrist Blood Pressure Monitor
• 00852547004603: BM47 Universal Cuff (replacement)
• 10852547004556: Glass Body Analysis Scale
• 10852547004457: BM47 XL Cuff (replacement)
• 10852547004396: Body Fat Scale
• 20852547004348: TENS Device
• 20852547004287: Upper Arm Blood Pressure Monitor * with cuff size 8.7 - 16.5 in (22 - 42 cm)
• 10852547004273: BM47 Blood Pressure Monitor with Universal Cuff (22 - 42 cm)
• 10852547004266: Body Fat Scale
• 10852547004211: Fingertip Pulse Oximeter (for wellness)
• 10852547004129: Non-contact IR Clinical Thermometer
• 10852547004112: Body Fat Scale
• 10852547004105: Infrared Lamp
• 20852547004058: Portable Nebulizer
• 00852547004009: IR EAR THERMOMETER DISPOSABLE PROBE COVERS
• 10850003500048: Infrared Lamp
• 10850003500031: Bluetooth® Upper Arm Blood Pressure Monitor * with cuff size 8.7 - 17.3 in (22 - 44 cm)
• 10850003500215: Fascia Massager (Light Wood)
• 20853879007144: EMS Abdominal Muscle Belt
• 10850003500161: Vital Legs EMS circulation stimulator for the feet and calves
• 10852547004181: Glass Body Analysis Scale
• 20850003500526: Digital TENS Device
• 20850003500502: Wrist Blood Pressure Monitor
• 20850003500434: Basal Thermometer with Ovy App
• 10850003500611: XL Cuff (33-43 cm) for use with Blood Pressure Monitor Model # BM35 (Type BM35/1)
• 00850003500676: SPEAKING BLOOD PRESSURE MONITOR - upper arm automatic-inflation electronic Sphygmomanometer, por
• 00850003500669: Massager
• 10850003500642: Non-contact IR Clinical Thermometer
• 10850018808009: Pulse Oximeter for use with sporting and aviation activities. Intended to monitor heart rate dur