Resp-O2 Oxygen CO2 Sampling Line

GUDID 00840117316089

Resp-O2 Oxygen CO2 7' (2.1m) Sampling Line with Filter, male/female connector

DYNAREX CORPORATION

Capnography sampling adaptor

• Primary Device ID: 00840117316089
• NIH Device Record Key: d2a572e4-bf93-48ef-aea4-e6ff81a8b6ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Oxygen CO2 Sampling Line
• Version Model Number: 33086
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00840117316089 [Package]; Contains: 00840117316164; Package: Case [25 Units]; In Commercial Distribution
GS1	00840117316164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143150

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: 2021-04-30
• Device Publish Date: 2021-04-22

On-Brand Devices [Resp-O2 Oxygen CO2 Sampling Line]

• 00840117316096: Resp-O2 Oxygen CO2 Pressure Line Filters
• 00840117316089: Resp-O2 Oxygen CO2 7' (2.1m) Sampling Line with Filter, male/female connector
• 00840117316072: Resp-O2 Oxygen CO2 7' (2.1m) Sampling Line with Filter; Male/Male Connector
• 00840117316065: Resp-O2 Oxygen CO2 7' (2.1m) Sampling Line Male/Female Connector
• 00840117316058: Resp-O2 Oxygen CO2 7' (2.1m) Sampling Line; Male/Male connector