Philips MR Patient Care LoFlo Cannula Line 989803183281

GUDID 10607411982047

MR Oatient Care Pediatric LoFlo CO/O2 Cannula

SALTER LABS

Nasal oxygen cannula, carbon-dioxide-sampling

• Primary Device ID: 10607411982047
• NIH Device Record Key: 39ab39c2-839a-4280-a5a6-07e4083e1bbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philips MR Patient Care LoFlo Cannula Line
• Version Model Number: P183281
• Catalog Number: 989803183281
• 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	00607411982040 [Primary]
GS1	10607411982047 [Package]; Contains: 00607411982040; 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 LoFlo Cannula Line]

• 10607411982047: MR Oatient Care Pediatric LoFlo CO/O2 Cannula
• 10607411982030: MT Patient Care Adult LoFlo Co2 with O2 Cannula