Philips MR Patient Care Sample Line 989803183261

GUDID 10607411982023

MR Patient Care Neonatal LoFlo C02 with Cannula

SALTER LABS

Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling

• Primary Device ID: 10607411982023
• NIH Device Record Key: f3ddee71-935a-45b6-890c-0825ea28780e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philips MR Patient Care Sample Line
• Version Model Number: P183261
• Catalog Number: 989803183261
• Company DUNS: 022721133
• Company Name: SALTER LABS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607411982026 [Primary]
GS1	10607411982023 [Package]; Contains: 00607411982026; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151421

FDA Product Code

• CCK: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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: 2023-07-17
• Device Publish Date: 2023-07-07

On-Brand Devices [Philips MR Patient Care Sample Line]

• 10607411982054: MR Patient Care LoFlo Co2 with Airway Adapters
• 10607411982023: MR Patient Care Neonatal LoFlo C02 with Cannula
• 10607411982016: MR Patient Pediatric LoFlo Co2 with Cannula
• 10607411982009: P183241