Resp-O2 EtCO2 Nasal Sampling Cannula

GUDID 00840117316553

Resp-O2 EtCO2 Nasal Sampling Cannula 10' (3.0m) Tubing, Male Luer Connector Adult Standard O2 Tubing Connector

DYNAREX CORPORATION

Carbon-dioxide-sampling nasal oxygen cannula

• Primary Device ID: 00840117316553
• NIH Device Record Key: 94e86054-98c9-43b2-a4f0-5ee07662682f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 EtCO2 Nasal Sampling Cannula
• Version Model Number: 33187
• 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	00840117316553 [Package]; Contains: 00840117316645; Package: Case [25 Units]; In Commercial Distribution
GS1	00840117316645 [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 EtCO2 Nasal Sampling Cannula]

• 00840117316560: Resp-O2 EtCO2 Nasal Sampling Cannula 14' (4.2m) Tubing, Male Luer Connector, Pediatric, Standard
• 00840117316553: Resp-O2 EtCO2 Nasal Sampling Cannula 10' (3.0m) Tubing, Male Luer Connector Adult Standard O2 Tu
• 00840117316546: Resp-O2 EtCO2 Nasal Sampling Cannula 10' (3.0m) Tubing, Male Luer Connector, Pediatric Standard
• 00840117316539: Resp-O2 EtCO2 Nasal Sampling Cannula 7' (2.1m) Tubing, Female Luer Connector, Adult, Standard O2
• 00840117316522: Resp-O2 EtCO2 Nasal Sampling Cannula 7' (2.1m) Tubing, Female Luer Connector, Pediatric, Standar
• 00840117316515: Resp-O2 EtCO2 Nasal Sampling Cannula 7' (2.1m) Tubing, Female Luer Connector, Infant, Standard O
• 00840117316508: Resp-O2 EtCO2 Nasal Sampling Cannula 7' (2.1m) Tubing, Male Luer Connector Adult, Standard O2 Tu
• 00840117316492: Resp-O2 EtCO2 Nasal Sampling Cannula 7' (2.1m) Tubing, Male Luer Connector, Pediatric, Standard
• 00840117316485: Resp-O2 EtCO2 Nasal Sampling Cannula 7' (2.1m) Tubing, Male Luer Connector, Infant, Standard O2
• 00840117320826: Resp-O2 EtCO2 Nasal Sampling Cannula, 10' (3.0 m) Tubing, Female Luer Connector, Adult, Universa
• 00840117319561: Resp-O2 EtCO2 Nasal Sampling Cannula, 7' (2.1 m) Tubing, Female Luer Connector, Adult, Universal
• 00840117318861: Resp-O2 EtCO2 Nasal Sampling Cannula, 7' (2.1 m) Tubing, Male Luer Connector, Adult, Universal O
• 00840117318854: Resp-O2 EtCO2 nasal Sampling Cannula, 7' (2.1 m) Tubing, Male Luer Connector, Pediatric, Univers
• 00840117318847: Resp-O2 EtCO2 Nasal Sampling Cannula, 14' (4.2 m) Tubing, Female Luer Connector, Adult, Standard
• 00840117318830: Resp-O2 EtCO2 Nasal Sampling Cannula, 14' (4.2 m) Tubing, Female Luer Connector, Pediatric, Stan
• 00840117318823: Resp-O2 EtCO2 Nasal Sampling Cannula, 10' (3.0 m) Tubing, Female Luer Connector, Adult, Standard
• 00840117318816: Resp-O2 EtCO2 Nasal Sampling Cannula, 10' (3.0m) Tubing, Female Luer Connector, Pediatric, Stand
• 00840117318809: Resp-O2 EtCO2 Nasal Sampling Cannula, 14' (4.2 m) Tubing, Male Luer Connector, Adult, Standard O