Capsule Surveillance

GUDID 03615041990332

CAPSULE TECHNOLOGIE

Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software

• Primary Device ID: 03615041990332
• NIH Device Record Key: d0c7fcbc-9762-4465-bb1e-c72848b3016c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capsule Surveillance
• Version Model Number: Capsule Surveillance System
• Company DUNS: 536805245
• Company Name: CAPSULE TECHNOLOGIE
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03615041990332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213335

FDA Product Code

• MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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: 2022-05-31
• Device Publish Date: 2022-05-23

Devices Manufactured by CAPSULE TECHNOLOGIE

• 03615041990332 - Capsule Surveillance: 2022-05-31
• 03615041990332 - Capsule Surveillance: 2022-05-31
• 03615040001640 - Capsule Vitals Plus: 2022-03-10 Vitals Plus Backpack
• 03615040001657 - Capsule Vitals Plus: 2022-03-10 Vitals Plus Backpack Oximeter Masimo
• 03615040001664 - Capsule Vitals Plus: 2022-03-10 Vitals Plus Backpack Oximeter Nellcor
• 03615040001671 - Capsule Vitals Plus: 2022-03-10 Vitals Plus Backpack Thermometer Exergen
• 03615040001688 - Capsule Vitals Plus: 2022-03-10 Vitals Plus Backpack Oximeter Masimo Thermometer Exergen
• 03615040001695 - Capsule Vitals Plus: 2022-03-10 Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen
• 03615040001701 - Capsule Vitals Plus: 2022-03-10 Vitals Plus Backpack Capno Masimo