iProvèn

GUDID 08719481721022

Dual mode thermometer

Masena Invest B.V.

Intermittent electronic patient thermometer

• Primary Device ID: 08719481721022
• NIH Device Record Key: 3de18079-7a04-483f-8a6b-3bd0632cdce8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iProvèn
• Version Model Number: DMT-316w
• Company DUNS: 491209290
• Company Name: Masena Invest B.V.
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• 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	08719481721022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131243

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-25
• Device Publish Date: 2017-08-23

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