iProvèn

GUDID 08719481721541

Oximeter

Masena Invest B.V.

Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter

• Primary Device ID: 08719481721541
• NIH Device Record Key: 6356fc0f-0e4f-4ee0-8226-b9f8397fcfc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iProvèn
• Version Model Number: Oxi-27
• 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	08719481721541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140582

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-11-10
• Device Publish Date: 2018-03-16

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