Capsule Surveillance

GUDID 03615041990332

CAPSULE TECHNOLOGIE

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