iProvèn

GUDID 08719481722029

Box with three midstream pregnancy tests

Masena Invest B.V.

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

• Primary Device ID: 08719481722029
• NIH Device Record Key: dd06064b-e8d4-4a25-9f83-60950480b65d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iProvèn
• Version Model Number: FMH-139-3
• Company DUNS: 491209290
• Company Name: Masena Invest B.V.
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08719481722029 [Primary]
GS1	08719481722036 [Unit of Use]

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-07-06
• Device Publish Date: 2018-04-02

On-Brand Devices [iProvèn]

• 00871948172070: Blood Pressure Monitor measuring around the wrist with Bluetooth
• 00871948172001: Blood Pressure Monitor with Bluetooth 10 units in one carton
• 08719481720780: Blood Pressure Monitors 45 units in one carton for measuring around the wrist with Bluetooth.
• 08719481720711: Blood Pressure Monitors 45 units in one carton for measuring around the wrist.
• 08719481720131: BPM-2244BT-A
• 08719481720124: BPM-2244BT-W
• 08719481720063: BPM-2244BT
• 08719481720490: Blood Pressure Monitor with Bluetooth 10 units in one carton
• 08719481722067: Dual mode thermometer with white cap
• 08719481721503: Triple mode thermometer with mute button
• 08719481721466: Dual mode thermometer
• 08719481721459: Dual mode thermometer
• 08719481721022: Dual mode thermometer
• 08719481720803: Dual mode thermometer
• 08719481720155: DMT-316
• 08719481720148: DMT-489-2
• 08719481720018: DMT-489-W
• 08719481720001: DMT-489
• 08719481721541: Oximeter
• 08719481722043: Box with five midstream pregnancy tests
• 08719481722029: Box with three midstream pregnancy tests
• 08719481721077: Fertility KIT with 30 teststrips
• 08719481721060: Box with 35 ovulation teststrips
• 08719481721053: Box with 50 ovulation teststrips
• 08719481721046: Box with 30 pregnancy teststrips
• 08719481720865: Fertility KIT with 70 teststrips
• 08719481720773: Box with 35 ovulation teststrips
• 08719481720766: Box with 50 ovulation teststrips
• 08719481720759: Box with 30 pregnancy teststrips
• 08719481720728: Box with 25 ovulation teststrips and 5 pregnancy teststrips
• 08719481720179: HCG strips - pregnancy test strips - REGISTRATION NUMBER HCG STRIP: 21 CFR 862.1155
• 08719481720162: HCG strips - pregnancy test strips